A randomized parallel group, open labelled active controlled clinical study to evaluate the safety and efficacy of habb-e-hindi in the management of waja-ul- mafasil murakkab (rheumatoid arthritis)

Rheumatoid Arthritis (RA) is a chronic, progressive, systemic autoimmune disorder characterized by symmetrical inflammatory polyarthritis, predominantly affecting the small joints of the hands and feet, leading to persistent pain, stiffness, swelling, and progressive joint deformities. In Unani medicine, the condition is described as Waja-ul-Mafasil Murakkab, which is believed to result from an abnormal mixture and imbalance of the humours—Balgham (phlegm), Safra (yellow bile), and Sawda (black bile)—often aggravated by cold temperament, poor digestion, excessive intake of unsuitable foods, and lack of physical activity. The prevalence of RA worldwide is estimated between 0.3–1% of the adult population, with nearly 18 million individuals affected globally, and in India the prevalence stands at approximately 0.75% as per ACR criteria. The disease exhibits a marked female predominance with a ratio of 3:1, and about 70% of the affected population consists of women, particularly between the ages of 40–70 years, where onset is most common. For the present clinical evaluation of Habb-e-Hindi, the inclusion criteria include adult patients aged 18–60 years of either sex, those who test positive for Rheumatoid Factor and Anti-Citrullinated Peptide Antibody (ACPA), and individuals fulfilling the ACR 2010 diagnostic criteria with a score of six or more. Exclusion criteria involve patients with other joint diseases, uncontrolled hypertension, diabetes mellitus, cardiovascular, renal, pulmonary, or hepatic diseases, pregnant and lactating women, individuals with a history of alcohol or drug abuse, those who have received intra-articular corticosteroids, and patients with coexisting autoimmune disorders. The test drug, Habb-e-Hindi, is a classical Unani formulation comprising Suranjan Sheeren (Colchicum luteum), Badang Babli (Ebelia ribes), Zanjabeel (Zingiber officinale), Muqil (Commiphora wightii), Asgandh (Withania somnifera), Bozidan (Tanacetum umbelliferum), Badhara (Stereospermum suaveolens), Musli Safed (Chlorophytum borivilianum), Sheetraj (Plumbago zeylanica), Mirch Siyah (Piper nigrum), Zeera Siyah (Cuminum cyminum), and Maweez Munaqqah (Vitis vinifera), all authenticated by a certified botanist before preparation. These ingredients are finely ground and processed into tablets, administered orally at a dosage of 2.5 g twice daily after meals with water, aimed at reducing joint inflammation, relieving pain, improving mobility, and restoring humoral balance. The control drug for comparison is Baricitinib 4 mg, administered once daily after meals, serving as an active comparator to assess the relative safety and efficacy of the Unani formulation. This structured approach allows a comprehensive evaluation of the therapeutic potential of Habb-e-Hindi in managing Waja-ul-Mafasil Murakkab (Rheumatoid Arthritis).