Efficacy and safety of Majoon Ushba oral and Marham Raal topical in tinea corporis - A randomized open-labeled active-controlled clinical trial.

OBJECTIVE: Tinea Corporis is the most frequent form of dermatophytosis reported as the commonest presentation. Majoon Ushba (MU) a polyherbal preparation in a semisolid oral dosage form and Marham Raal (MR) an ointment made up of herbal and animal drugs are used for skin disorders in Unai medicine. Considering the biologically active substances with antioxidant, antimicrobial, antifungal, anti-inflammatory, and wound-healing properties of their ingredients, this study aimed to evaluate the clinical and mycological efficacy and safety of MU and MR in tinea corporis. METHODS: This randomized open-labeled active-controlled clinical trial was conducted on 42 patients of tinea corporis. Patients were randomly assigned via a computer-generated list to the test group (n=21) receiving oral MU (6 gm) with topical MR and the control group (n=21) topical terbinafine hydrochloride (1%) for 40 days. The severity scores of clinical symptoms; erythema, scaling, itching, margins, and size were the primary outcome and the mycological cure (negative KOH microscopy), total score, and dermatology life quality index (DLQI) were the secondary outcomes were analyzed at baseline and at 40 days. RESULTS: A significant reduction was observed in clinical severity scores of erythema, scaling, and itching (P ≤ 0.05) in both groups except for margins, and size of the lesion (P ≥ 0.05). The mycological cure (P = .001) and the total score (P = 0.0002) and DLQI (P = 0.002) were statistically significant in both groups when analyzed from baseline to the end of the treatment within groups, however, the differences in these outcomes were statistically insignificant (P ≥ 0.05) on the inter-group comparison. All the safety parameters (clinical and laboratory) were in the normal range in both groups. CONCLUSION: The results demonstrated that traditional and conventional treatments were equally effective and MU and MR can be prescribed as alternative or complementary treatments for tinea corporis.

Efficacy of Jawarish Shahi a herbal formulation in irritable bowel syndrome: An open-labeled single-arm clinical trial.

Background and aim: Irritable bowel syndrome (IBS) is one of the most common gastrointestinal disorders characterized by chronic recurrent abdominal pain related to a change in bowel habit or defecation frequency and commonly accompanied by anxiety and depression affecting about 10% population globally. Jawarish Shahi (JS) is a special dosage form prepared for gastrointestinal disorders in Unani medicine containing Phyllanthus emblica L., Terminalia chebula Retz., Coriandrum sativum L., Elettaria cardamomum (L.) Maton and Salix caprea L. Considering the antioxidant, immunomodulatory, antispasmodic analgesic, antidiarrheal, antisecretory, laxative, anti-inflammatory, anxiolytic, and antidepressant properties, the present study was aimed to evaluate the efficacy of JS in IBS. Experimental procedure: This single-arm open-labeled clinical trial was conducted on 26 male and female patients of IBS according to Rome IV criteria, aged 18-50 years with moderate symptoms. JS was given 7 g orally twice a day after meal with water for 45 days. IBS Severity Scoring Scale (IBS-SSS) was used for efficacy outcomes and the difference was analyzed from baseline to the subsequent follow-ups. Results: Data analysis of subsequent followup showed a significant decrease in IBS-SSS scores except for 2nd followup, scores decreased from 229.50 ± 75.91 to 203.12 ± 71.71 (p < 0.1018), 150.61 ± 55.32 (p < 0.0001), and 123.76 ± 54.81 (p < 0.0001) at 0, 15th, 30th, 45th day of follow up respectively. Conclusion: The present study revealed that JS is safe and effective in reducing the overall symptoms of IBS in respect to its severity and impact on quality of life and can be used as an alternate as well as a complementary treatment in IBS.

Jawarish Shahi: A special dosage form of herbal formulations for functional gastrointestinal disorders in Unani medicine- A comprehensive review.

ETHNOPHARMACOLOGICAL RELEVANCE: Functional gastrointestinal disorders (FGIDs) are the most common diagnoses in gastroenterology and represent a group of chronic unexplained gut syndromes. The best-known disorders are irritable bowel syndrome (IBS) and functional dyspepsia (FD). Jawarish Shahi (JS) is used for gastrointestinal disorders in Unani Medicine (UM). AIMS OF THE STUDY: The present review aims to evaluate the FD and IBS in Unani medicine and scientific evidence for the safety and efficacy of JS and its herbal ingredients in the management of FD and IBS. MATERIAL AND METHODS: Sources of data are from the classical literature of UM, Canon of medicine, Khazainul Advia, Indian Medicinal Plants-An Illustrated Dictionary. Databases, PubMed, Science Direct, Scopus, Google Scholar, were explored for related studies. RESULTS: An updated review on the concept of FGIDs in Unani medicine, its pathophysiology, and management is presented. Comprehensive information on JS and its traditional and ethnopharmacological clinical attributes, standardization and toxicity study, biomedical studies of herbs in JS for their efficacies in FD and IBS are presented. CONCLUSIONS: The outcome of the work clearly indicates that disease conditions similar to FD and IBS and their successful treatment are described in Unani Medicine. JS has been used for disease conditions similar to FD and IBS by the physicians of the medieval period. The herbs in JS are widely researched for pharmacologically active substances and were reported for antioxidant, immunomodulatory, gastroprotective, antispasmodic, analgesic, antidiarrheal, antisecretory, laxative, anti-inflammatory, anxiolytic, and antidepressant properties. Nevertheless, further explorations, particularly well-designed clinical trials are required for efficacy.

The efficacy and safety of herbal combination of Unani Medicine in chronic urticaria: A randomized, controlled study.

Background and Aim; Chronic urticaria (CU) is a fluctuating and pruritic erythematous papule that persists for over six weeks. It affects 0.5-1% of the population and interferes with subjective well-being and daily life. Its etiology is highly complex which makes a causal and/or curative treatment difficult. Nonsedating H1-antihistamines are given as symptomatic therapy, which reduces symptoms effectively in <50% of patients. In Unani medicine, urticaria is known as Shara and treated according to its established etiology. The present study objective was to investigate the effect of herbal combination of Unani medicine (HCUM) comprising Rosa damascena Mill, Bambusa arundinacea Linn, Cinnamomum camphora Linn, Mentha arvensis Linn, in comparison with Levocetirizine in CU. Experimental procedure; This randomized open-labeled standard control clinical trial was conducted between 42 male/female patients aged 20-50 years with moderate to severe CU who were randomly allocated in a 3:1 ratio into HCUM and Levocetirizine 5 mg groups. HCUM powder 5.125 Gm and Levocetirizine 5 mg were given for 4 weeks. Urticaria activity score (UAS7) and chronic urticaria quality of life questionnaire (CU-Q2oL) were primary and secondary outcomes and analyzed per protocol. Results: A total of 40 patients completed the study. Data analysis showed a significant decrease (P=<0.001) in the scores of UAS7 (32.43 ± 2.34-14.03 ± 2.16 and 32.10 ± 2.33-28.40 ± 3.78) and CU-Q2oL (67.57 ± 9.56-36.50 ± 3.01 and 65.20 ± 11.78-59.60 ± 11.13) in HCUM and Levocetirizine groups respectively. Conclusion: As an alternative treatment in terms of safety, efficacy, tolerability, and quality of life the HCUM treatment proved to be more effective than Levocetirizine 5 mg in moderate to severe CU.

Clinical efficacy of medicinal leech therapy in treating third- and fourth-degree hemorrhoids / Eficácia clínica da hirudoterapia no tratamento de hemorroidas de terceiro e quarto graus

Abstract Objectives Hemorrhoids are characterized by bleeding, mucous discharge, itching, pain, and prolapse. This condition is known as bawaseer in Unani medicine, and Hirudinaria granulosa has been used for its treatment in Irsal-e Alaq, or medicinal leech therapy (MLT), for centuries. Hirudinaria granulosa with antithrombotic and antiinflammatory action is used in the treatment of chronic venous disease and hemorrhoids. The present study was aimed to investigate the efficacy of MLT in third and fourth-degree hemorrhoids. Methods A single-centre prospective, clinical trial with a pre and postanalysis design was conducted at the hospital of the National Institute of UnaniMedicine. Twenty male and female patients, with a mean age of 38 years, presenting moderate symptoms assessed with the colorectal evaluation of clinical therapeutics scale (CORECTS) questionnaire were included in the study. Hirudinaria granulosa were applied around the pile mass for 15 minutes weekly, for 4 weeks. The efficacy of the treatment was measured by an objective and subjective assessment using the CORECTS. Results When analyzed by the clinician, MLT reduced the symptoms' severity score in the following domains: pain (55% improvement; p < 0.001); anorectal itching (30% improvement; p < 0.10); and bleeding (10% improvement; p < 0.7963). Significant improvement (p < 0.001) was reported in the CORECTS score in relation to pain (44.09% improvement; p < 0.001), itching (38.55% improvement; p < 0.001), swelling (44% improvement; p < 0.001), bleeding (17.28% improvement; p < 0.007), discomfort (34.01% improvement; p < 0.001), and wellbeing (32.35 % improvement; p < 0.001), giving an average overall opinion on the therapy of 4/10. Conclusion The results of the study albeit smaller in sample size show that MLT is an effective and safe therapeutic option in reducing the symptoms of 3rd and 4th degree haemorrhoids.

Resumo Objetivos As hemorroidas são caracterizadas por sangramento, secreção mucosa, prurido, dor e prolapso. Esta condição é conhecida como bawaseer namedicina Unani, e a Hirudinaria granulosa tem sido usada para seu tratamento na Irsal-e Alaq, ou hirudoterapia, há séculos. A H. granulosa, devido à sua ação antitrombótica e antiinflamatória, é utilizada no tratamento de doenças venosas crônicas e hemorroidas. O presente estudo teve como objetivo investigar a eficácia da hirudoterapia em hemorroidas de terceiro e quarto graus. Métodos Este ensaio clínico prospectivo e unicêntrico com delineamento pré e pósanálise foi conduzido no hospital do National Institute of Unani Medicine. Foram incluídos no estudo 20 pacientes de ambos os sexos, com média de idade de 38 anos, que apresentavam sintomas moderados avaliados pelo questionário colorectal evaluation of clinical therapeutics scale (CORECTS). Espécimes de H. granulosa foram aplicadas em volta da área afetada por um período de 15 minutos semanais, durante 4 semanas. A eficácia do tratamento foi medida por uma avaliação objetiva e subjetiva usando o questionário CORECTS. Resultados Quando analisada pelo clínico, a hirudoterapia reduziu o escore de gravidade dos sintomas nos seguintes domínios: dor (55% de melhora; p < 0,001); prurido anorretal (melhora de 30%; p < 0,10); e sangramento (melhora de 10%; p < 0,7963). Melhora significativa (p < 0,001) foi relatada no escore CORECTS em relação à dor (44,09% de melhora; p < 0,001), prurido (38,55% de melhora; p < 0,001), inchaço (44% de melhora; p < 0,001), sangramento (17,28 % de melhora; p < 0,007), desconforto (34,01% de melhora; p < 0,001) e bem-estar (32,35% de melhora; p < 0,001), o que resultou em uma opinião geral média sobre a terapia de 4/10. Conclusão Os resultados do estudo, embora com tamanho de amostra pequeno, mostram que a hirudoterapia é uma opção terapêutica eficaz e segura na redução dos sintomas de hemorroidas de terceiro e quarto graus.

Efficacy of Khar-i-khasak (Tribulus terrestris Linn.) in prehypertension: a randomized, double-blind, placebo-controlled trial.

BACKGROUND: Prehypertension is a state of above-normal blood pressure that does not meet the criteria for the diagnosis of hypertension and its prevalence estimated in population-based samples ranges from 22 to 52%. It conveys potentially many deleterious consequences such as high risk of progression to hypertension and cardiovascular disease later in life. OBJECTIVES: The present study was conducted to evaluate the blood pressure-lowering effect of Khar-i-khasak (Tribulus terrestris Linn.) in prehypertensive individuals. METHODS: This randomized, double-blind, placebo-controlled, clinical trial was conducted at the National Institute of Unani Medicine, Hospital, Bengaluru, after approval by the Institutional Ethics Committee. Prehypertensive individuals over 18 years of age were enrolled after obtaining their written informed consent and were randomly allocated to the test or placebo group. The test and placebo groups were administered powdered dried fruits of Khar-i-khasak (6g) and matched placebo (6g) in three divided doses for two months respectively. The efficacy assessment was determined by changes in systolic and diastolic blood pressures. RESULTS: Both systolic and diastolic blood pressure showed a significant decline in the test group (p<0.001) as compared to the placebo group. The average decline in systolic/diastolic blood pressure was -7.7/5.5 mmHg in the test group and -1.9/0.2 mmHg in the placebo group. During the post-therapy follow-up period, no prehypertensive developed full-blown hypertension in either group. Safety parameters were found to be within normal limits. CONCLUSIONS: The test drug Khar-i-khasak (T. terrestris Linn.) was found to be effective and safe in lowering blood pressure compared to placebo in prehypertensive individuals.