Pharmacovigilance in Unani Medicine

Objective: There are certain clear negative effects linked to traditional therapies for benign prostatic hyperplasia (BPH), such as invasive surgery and 5alpha-reductase inhibitors. On the other hand, there is some evidence that alternative medications are safer and may help individuals with BPH with their sexual dysfunction as well as their quality of life and lower urinary tract symptoms (LUTS). An review of BPH, various approaches to its treatment, and its significance in the Unani system of medicine—one of the alternative medical systems—were the main goals of the current article. Methods: PubMed, Scopus, Science Direct, Web of Sciences, Google Scholar databases and classical texts of unani medicine were searched for data collection. Results: BPH, which is classified under the Unani medical system as Waram unuq almathana (bladder neck swelling) and Insidad majra-i-mathana (bladder outlet obstruction), has been treated with herbal remedies for centuries but still needs thorough scientific verification. Notable among the herbs include Linum usitatissimum, Urtica dioica, Tribulus terrestris, and Cucurbita pepo. Conclusion: For achieving the goal of LUTS-free ageing men, and safer and cost-effective future management of BPH, Unani herbal medicine could hopefully prove beneficial. Keywords: Prostatomegaly; Warm-e-Ghudda-e-Mazi; Micturition; Unani Medicine

Background: Unani System of Medicine (USM) is one of the traditional systems of medicine practiced in India and the Indian subcontinent. It is a holistic system of health care based on inceptive principles applied by Hippocrates, Galen, and Ibn-e-Sina, the founders of present-day medicine. USM encompasses a distinct way of looking at the human body and it considers health to be the result of natural dynamic harmonious balance within the body. USM also recognizes the presence of inherent wisdom which is responsible for controlling all physiological functions, maintenance of health, restoration of health, and self-healing. This intrinsic ability of the body to restore health and the mechanism that activates the body’s healing process is called Tabi’at/ physis. The ultimate goal of prevention of disease can be obtained by optimization of tabi’at/physis, increasing the host defense. It can be achieved through the implication of asbab-e-sitta zarooriyah which includes some Unani Regimenal Therapies also, fostering change in lifestyle habits resulting in good health. Aims: In this raging pandemic all the therapeutic strategies are based on destroying the agent, breaking the means of transmission and immunization. Although we are leaving behind a huge gap in maintaining the host defense even though it has a crucial role in disease dynamics. In this paper, we have attempted to highlight the concept of tabi’at/Physis and its optimization to prevent this disease and its transmission. Methods: The authors had gone through classical Unani medical textbooks books related to the concept of tabi’at, asbab-e-sitta zarooriyah, and various modalities that help in health promotion and host defense. Important Unani medicine textbooks like Al Qanoon, Kamilus Sana’at, Kitab-al- Hawi, Al-asbab wa Alamat, Moalijat Buqratiya, Firdausul Hikmat and Kitabul Mansuri in addition to other published literature on the concerned subject was also reviewed for further clarification on the topic. Keywords: Unani System of Medicine, Tabi’at (physis), Host defense & Asbab-e- Sitta zarooriyah

Every health care system must be evidence based and Unani system of medicine ought to be no exception. An evidence base is needed at every level of health-care, right from diagnostics to the therapeutic decision making. Unani medicine requires thorough work to bring out evidence basis not only to support its interventions but also to its fundamental concepts to create scientific and logical basis on which therapeutic decisions are made. However, when pleading for evidence, problems associated with the nature of evidence and their relevance to Unani system of medicine ought to be thoroughly debated. Though Unani system and biomedicine share the same spirit of open and sincere scientific enquiry, their fundamentals, epistemology, logic and theories are distinct. Unani medicine is basically holistic, whereas biomedicine is reductionist. These epistemic variations call for the use of appropriate and acceptable research methods by involving experts from Unani system and biomedicine. The classical approach of this system should not be compromised for the convenience of prevailing research strategies. Various research strategies like reverse pharmacology to unravel the mechanism of action of drugs, pharmaco-epidemiology to study the toxicity of herbo-mineral preparations, retrospective treatment outcome surveys as a starting line to study the efficacy of drugs and whole system research to evaluate the efficacy of packaged interventions have been proposed by scientists to generate evidence in traditional medicine, that are also applicable to Unani system of medicine. In this paper research methods, which are appropriate to generate scientific evidence in Unani medicine are discussed.

Diarrhea (also known as Is’haal in Unani system of medicine) remains a leading cause of mortality and morbidity worldwide, particularly affecting children in the resource-limited settings. Conventional treatments often involve antibiotics, which may not always yield long-term relief and can contribute to antimicrobial resistance. This study explores the potential of Unani medicine as an alternative treatment for diarrhea in pediatric patients. To evaluate the efficacy of Unani formulations in the treatment of recurrent diarrhea in a pediatric patient. We report the case of a 4-year-old male with a 2-year history of recurrent loose stools, who was treated unsuccessfully with conventional antibiotics. He was evaluated as per the Unani principles based on Arqaan, Akhlaat, Quwa, and Mizaaj. He was prescribed a combination of Unani formulations Dafay Ishaal (anti-diarrheal), Habis and Qabiz (styptic and astringent), Muqawwi-e-Jigar (hepatoprotectives), and Muqawwiya (general tonic). Within 5 days of commencing Unani treatment, the frequency of loose stools reduced from 7–8 times per day to two times per day. By the end of the 15-day treatment course, the patient exhibited only 1 loose stool per day, with significant improvement in general health and appetite. The patient did not require any conventional treatments during this period. This case highlights the effectiveness of Unani medicine in managing recurrent diarrhea in pediatric patients. The observed clinical improvements suggest that Unani formulations can serve as a viable alternative or complementary approach to conventional treatments. Further research and clinical trials are warranted to validate these findings and to integrate Unani medicine into broader diarrhea management protocols.

Background: Eczema, is a common chronic skin condition that can lead to recurrent infections and poor quality of life if left untreated. This paper presents the case of a 30-year-old male patient, who came to the outpatient department (OPD) of the Kashmir Tibbia College Hospital and Research Centre, Shilvath, Bandipora, Kashmir, India. Clinical presentation: His chief complaints were lesions on the palm of his left hand for one year. The patient also complains that his skin is black and thickened with severe itching on the affected area. Diagnosis: The patient was diagnosed clinically with hand eczema resembling Nar-e-Farsi in the Unani system of medicine. Interventions: For 30 days, Marham Kafoor was topically applied twice a day at a dose of 8-10 gm. Outcome: The patient was assessed before, the 15th day and 30th day of treatment based on the EASI, POEM, and VAS. Results: After the intervention, significant improvement was observed in all scales from baseline to 30th day. EASI changes from 18 (moderate) to 5 (mild), POEM changes from 19 (severe) to 7(mild), and VAS from 8 (severe) to 1 (mild). Conclusion: Marham Kafoor has been proven beneficial in treating hand eczema and enhancing patients' quality of life Keywords: Eczema; Marham Kafoor; Unani Medicine

Karafs, obtained from the entire plant of Apium graveolens L. (family Apiaceae),is a versatile herb widely recognized in various cultures. Its seeds, also called as Tukhm-e-Karafs in Unani system of medicine, are utilized globally as a spice, while the leaves and roots serve as components in culinary salads. Known by names such as Apio (Spanish), Céleri (French), Selderij (Dutch), Qin Cai (Chinese), and Syelderey (Russian), this plant is cultivated across regions including North Africa, Europe, Western Asia, and parts of India such as Himachal Pradesh, Uttar Pradesh, and Punjab. In Unani medicine, Karafs seeds are employed either alone or in compound formulations to address a range of health conditions. Pharmacologically, the seeds exhibit properties such as hepatoprotective, diuretic, and lithotriptic effects. In Unani medicine, the seeds are recognized for properties such as Kāsir-i-Riyāh (carminative), Dafi‘-i-Tashannuj (antispasmodic), Mufattit-i-Hasāh (lithotriptic), and Mudirr-i-Bawl (diuretic). These properties make them effective in managing ailments such as Hasāh al-Kulya (nephrolithiasis), Istisqā’ (edema), Nafkh al-Mi‘da (flatulence), and Ihtibās al-Baul (urinary retention). The widespread cultivation and multifaceted applications of Apium graveolens underscore its significance in both traditional and complementary medical systems.

Unani System of Medicine is also known as Greco-Arabic medicine, and developed into an elaborate scientific medical system by Arab and Persian physicians, such as Rhazes (850-925AD), Avicenna (980-1037AD), Al-Zahrawi and Ibn Nafis. It is practiced in India since eighth century AD and is a recognized Indian traditional system of medicine with good infrastructure for education; research and manufacturing unitswhich are well regulated by the Government. In Unani medicine there are well developed pharmacopeia and pharmaceutical processings for single & compound formulations for the treatment of several local and systemic ailments. The most important formulation among various Unani formulations is Sharbat-e-Unnab, a Unani pharmaceutical preparation acting as Dafa-e-Sual (antitussive), Khashunat-e-Halaq (sore throat), Musaffi-e-Khoon (blood purifier), Musakkin-e-Hiddat-e-Khoon (suppressive blood heat) etc. Unnab (Ziziphus jujuba Mill. / Jujube) fruit is the main ingredient of the formulation. Unnab is also an ingredient of Unani Joshanda which has been recommended for relief in upper respiratory tract symptoms in mild cases of COVID-19. Few scientific studies related to Sharbat Unnab have been conducted in problems like Acne vulgaris and Primary Hypertension. Apart from this Unnab, the main ingredient has also been studied for its antioxidant and anti-cancerous activities. This formulation is being used by Unani physicians since time immemorial. Therefore, this paper will describe the brief review of the formulation along with its ingredient.
 Keywords: Sharbat-e-Unnab, Unani medicine, Sharbat, Unnab, Ziziphus Jujuba Mill.

The Unani system of medicine is rooted in the Theory of Humors, where health is maintained through the balance of four bodily fluids (blood, phlegm, bile, and black bile). Its treatment approach is holistic, encompassing Ilaj bil Tadbeer (Regimental therapy), Ilaj bil Ghida (Dietotherapy), Ilaj bil Dawa (Pharmacotherapy), and Ilaj bil Yad (Surgery). Huqna (enema) is a key non-pharmacological regimen therapy in Unani medicine, used to cleanse the bowels and restore humoral balance. Its roots trace back to ancient Greek physicians like Hippocrates and Galen. This integrative review aims to provide a comprehensive understanding of Huqna therapy, exploring its historical, philosophical, and practical aspects while bridging traditional Unani practices with modern medical paradigms. A review of classical Unani literature and modern scientific sources was conducted. Historical texts were analyzed alongside contemporary studies on enema therapy in modern medicine. Relevant English-language literature up to 2024 was evaluated. The study highlights the definition, principles, and therapeutic applications of Huqna in traditional Unani medicine and compares them with the diagnostic and therapeutic uses of enemas in modern healthcare. Key convergences include their shared utility in managing bowel disorders and inflammatory conditions, while divergences emerge in procedural advancements and safety considerations. Huqna therapy demonstrates significant potential as a complementary approach in modern healthcare. However, further research is needed to validate its efficacy and address limitations. This analysis fosters a deeper understanding of Huqna therapy, encouraging its integration into contemporary medical practice. Huqna, Enema, Unani Medicine, Integrative Medicine, Traditional Therapy.

Published on:June 2022Journal of Young Pharmacists, 2022; 14(2):140-155Review Article | doi:10.5530/jyp.2022.14.28 Authors: MD Aftab Alam1, Mohammad Zakir1,*, Ahmed Minhajuddin1, Uzma Viquar1, Tasleem Ahmad2, Kuna Lahari2 1Department of Ilmul Advia (Unani Pharmacology), National Research Institute of Unani Medicine for Skin Disorders (NRIUMSD), AG Colony Road, Hyderabad, Telangana, INDIA.2Department of Biochemistry, National Research Institute of Unani Medicine for Skin Disorders (NRIUMSD), AG Colony Road, Erragadda, Hyderabad, Telangana, INDIA. Abstract: Since December 2019 world faces a respiratory pandemic named Coronavirus disease-19 (COVID-19). COVID-19 is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The term epidemic was coined by Hippocrates who is considered the father of Unani medicine which is based on four humours. In the Unani System of Medicine (USM) equivalent term for the epidemic is Wabā’. In classical Unani literature symptoms of Nazla-i-Wabā’iyya and Humma-i-Wabā’iyya closely resemble the symptoms of COVID-19. Major manifestations of this outbreak are cough, fever, headache, nausea, and breathlessness. This pandemic takes place due to a change in the quality of the surrounding air. We searched different databases electronically using the terms “COVID-19 or Coronavirus”, “Wabā› or infectious disease”, “Unani immunomodulators”, ‘’Herbal immunomodulators’’, ‘’Anti-viral herbal drugs’’, Herbal fumigation and “Nazla-i-Wabā’iyya or Nazla Wabā’ī”. We also gone through different classical textbooks of USM available in the NRIUMSD library. We reviewed the concept of Wabā’, its prevention, and management strategies available in USM. We also searched antiviral, immunomodulation, fumigation activities of Unani drugs. Unani physicians advocated general measures of physical distancing, health hygiene, isolation, quarantine, and immunomodulation. As a preventive measure, various immunomodulatory drugs like Asgandh, Aam, Babuna, Gilo, Satawar, and Kalonji and antidotes such as Tiryāq Wabā’i have been described in the literature. The ingredients of Tiryāqi- Wabā’i include Aloe barbedensis, Crocus sativus, and Commiphora myrrha. Several fumigants like Sandal, Ood, Kafoor, Loban, and Jhau are also mentioned in the management of the epidemic. For symptomatic management various antiviral, antipyretic and antitussive drugs are described well. Many evidence-based studies have already been reported for single drugs and formulations used in the USM. The Khamira Marwareed possesses antiviral, cardiotonic, and immunomodulatory activity. Single drugs such as Khaksi, Asgandh, Adusa, Chiriata, and Zanjabeel possess antipyretic, immunomodulatory, antitussive, antibacterial, and antiviral activities respectively. The knowledge from classical Unani literature and scientific researches may be useful in the prevention and management of COVID-19 like epidemic diseases. This review article aims to find out the concept of the pandemic, prevention, and management strategies existing in the USM.Key words: Amrād Wabā’ī, COVID-19, Epidemic, Humours, Kaifyat, Unani medicine, Wabā.

The pharmacovigilance program in Nepal is less than a decade old, and is hospital centered. This study highlights the findings of a community based pharmacovigilance program involving the community pharmacists. To collect the demographic details of the patients experiencing adverse drug reactions (ADR) reported by the community pharmacists; to identify the common drugs causing the ADRs, the common types of ADRs; and to carry out the causality, severity and preventability assessments of the reported ADRs. The baseline Knowledge-Attitude-Practices (KAP) of 116 community pharmacists from Pokhara valley towards drug safety was evaluated using a validated (Cronbach alpha=0.61) KAP questionnaire having 20 questions [(knowledge 11, attitude 5 and practice 4) maximum possible score 40]. Thirty community pharmacists with high scores were selected for three training sessions, each session lasting for one to two hours, covering the basic knowledge required for the community pharmacists for ADR reporting. Pharmacist from the regional pharmacovigilance center visited the trained community pharmacists every alternate day and collected the filled ADR reporting forms. Altogether 71 ADRs, from 71 patients (37 males) were reported. Antibiotics/ antibacterials caused 42% (n=37) of the total ADRs followed by non steroidal anti-inflammatory drugs [25% (n=22)]. Ibuprofen/paracetamol combination accounted for ten ADRs. The most common type of ADR was itching [17.2 % (n=20), followed by generalized edema [8.6 % (n=10)]. In order to manage the ADRs, the patients needed medical treatment in 69% (n=49) of the cases. Over two third (69%) of the ADRs had a 'possible' association with the suspected drugs and a high percentage (70.4%) were of 'mild (level 2)' type. Nearly two third [64.7 % (n=46)] of the ADRs were 'definitely preventable'. The common class of drugs known to cause ADRs was antibacterial/ antibiotics. Ibuprofen/ Paracetamol combination use of the drug was responsible for more number of ADRs and the most common ADRs were related to dermatological system. Strengthening this program might improve safe use of medicines in the community.

Hypothyroidism is the most common thyroid disorder, affects women more frequently, and incidence increases with age. The prevalence of hypothyroidism in developed countries is around 4-5%, whereas, in India, it is about 11%. The common symptoms of hypothyroidism in adults are weight gain, fatigue, lethargy, cold intolerance, constipation, change in voice, and dry skin. It can affect all systems of the body. Diagnosis is mainly based on clinical history and laboratory investigations. Untreated hypothyroidism increases morbidity and mortality. In conventional medicine, the treatment of choice is Levothyroxine, whereas in Unani System of Medicine, pharmacotherapy consists of single and compound drugs. Single drugs are selected as per the constitution (Mizaj) of drugs as opposed to the abnormal constitution (Su-e-Mizaj) of disease and its pathology. Some drugs increase the basal metabolic rate whereas some evacuate the morbid material from the body by the action of purgation. The drugs are used either in a single form or as a prescription of more than one drug in the form of decoction (Joshandah), infusion (Kheshandah), or powder (Safoof). This review aims at providing comprehensive information regarding various drugs used in Unani system of medicine that is used in the management of thyroid dysfunction.

The concept of functional foods includes foods or food ingredients that exert beneficial effect on health and reduce the risk of chronic diseases. Cereals are an excellent source of minerals, vitamins, macronutrients as well as micronutrients required for adequate health. Evidences showed that consumption of whole grains and their products is associated with a reduction of the risk of developing many diseases, including hypertension, stroke, metabolic syndrome, diabetes, and cancer. Unani medicine has discussed vividly and in a very comprehensive manner about cereals and grains. Wheat, rice, maize and barley etc. are used in various dosage forms as functional food and as adjuncts in the management of various ailments of the body due to their nutritional, anti-inflammatory, antioxidant and organ protective activities among others. The aim of penning this chapter is bring into the limelight the properties, nutritional value, therapeutic uses of cereals and grains and their utilization as food and formulated foods as described in Unani system of medicine.

Although distigmine is known to sometimes cause severe adverse drug reactions (ADRs), such as cholinergic crisis, there are limited data on the risk factors for these ADRs. In this study, we defined a serum cholinesterase (sChE) cutoff level for early detection of ADRs to distigmine and sought to identify risk factors for these ADRs based on this value. This retrospective cohort study included all patients who were prescribed distigmine and underwent measurement of sChE over a period of 8 years at Kaetsu Hospital. Ninety-three patients were included. The sChE cutoff level below which there was an increase in risk of ADRs was defined as 129 U/L based on the levels in patients who had ADRs by receiver operating characteristic analysis. The percentage of ADRs tended to increase with advancing chronic kidney disease (CKD) stage. Multivariate logistic regression analyses showed that a distigmine dose >0.1 mg/kg/d (odds ratio 3.19, 95% confidence interval 1.24-8.19) and age >85 years (odds ratio 3.04, 95% confidence interval 1.18-7.82) were positively associated with an sChE level ≤129 U/L. An sChE cutoff level of 129 U/L is a useful predictor of the risk of an ADR to distigmine, and dose per body weight, age, and CKD progression may pose potential risk of an ADR to distigmine. Therefore, for patients taking distigmine who have these risk factors, the risk of a severe ADR to distigmine can be reduced by decreasing the dose of distigmine and close monitoring of the sChE level.

The potential risk of adverse drug reactions (ADRs) in the paediatric population has become a public health concern and regulatory agencies in Europe and the US have acknowledged that there is a need for more research in this area. Spontaneous reporting systems can provide important new information about ADRs. To characterize ADRs in children reported in Denmark over a period of one decade. We analysed ADRs reported to the Danish Medicines Agency from 1998 to 2007 for individuals aged from birth to 17 years. Data were analysed with respect to time, age and sex, category of ADR (System Organ Class [SOC]), seriousness, suspected medicines (level 2 of the Anatomical Therapeutic Chemical [ATC] Classification System) and type of reporter. 2437 ADR reports corresponding to 4500 ADRs were analysed. On average, 234 ADR reports were submitted annually, corresponding to approximately two ADRs per report. From 2003 to 2005, an increasing number of ADRs submitted per report were observed, but after 2005 the reporting rate decreased. One-half of ADRs were reported for infants from birth to 2 years of age. Similar total numbers of ADRs were reported for boys and girls. The majority of ADRs reported were from the following SOCs: general disorders and administration site conditions (31%), skin and subcutaneous tissue disorders (18%) and nervous system disorders (15%). Reports encompassed medicines from ATC group J: vaccines and anti-infectives for systemic use (65%); and ATC group N: nervous system (17%). On average, 42% of ADRs were classified as serious. ATC group N had the highest proportion of ADRs that were classified as serious. Although physicians reported approximately 90% of the ADRs, a relatively large proportion of serious ADRs were reported by other sources. In Denmark, the ADR reporting rate in the paediatric population has declined since 2005. The majority of ADRs reported in young children were reported for vaccines and anti-infectives, but also a high number of serious ADRs were reported for medicines from ATC group N. The Danish Medicines Agency should monitor prescribing patterns more tightly to identify potential risks in the paediatric population in relation to the evolving pattern of medicine use among children.

Background: Low back pain has been a significant public health issue since long time, resulting in loss of functional productivity and medical costs. Nonspecific low back pain (NSLBP) or pain for which there is no known cause, affects about 85% of sufferers. Although there are conservative treatments accessible in the conventional medical system, like NSAIDs, which produces certain side effects. Unani system of medicine is the ancient system of medicine which deals with prophylactic and therapeutic management of many illnesses with no or least adverse effects. Objectives: To evaluate the effect of Unani compound pharmacopeial drug i.e., Habb-e-Gule-Aak (HGA) and exercises of lumbo-pelvic muscles (strengthening and stretching) in the management of NSLBP. Materials and Methods: Five patients with a primary report of chronic NSLBP (>6 months) without radiculopathy were treated with 2 pills of HGA twice daily for 30 days. The effectiveness of therapy was assessed on baseline, 15th day and 30th day using a numeric rating scale (NRS) to measure pain reduction and Oswestry disability index (ODI) to assess the decrease in lower back disability in NSLBP. Results: HGA and exercises of lumbo-pelvic muscles (strengthening and stretching) significantly reduced pain and disability in NSLBP. Conclusion: This case series is preliminary research of the use of multiple modalities in the management of NSLBP. It is envisaged that additional experimental research will be done to demonstrate the efficacy of this combination in treating people with NSLBP. Keywords: Habb-e-Gule-Aak, Ilaj Bit Tadbir, Lower back Exercise, Non-Specific Low back pain, Unani medicine