Multicentric Observational Studies of Polyherbal Unani Oral & Local Formulations in Cases of Rheumatoid Arthritis

Wajaul Mafasil (Rheumatoid arthritis) has become one of the most pressing global public health problems. In India alone an estimated 1% population is suffering from W M. Wajaul Mafasil which is a future threat to the physical, psychological, social and economic well being of the human beings. It often deprives people of their freedom and independence and can disrupt the lives of family members and other care givers. Physical symptoms of arthritis, pain, loss of joint movement and fatigue puts individuals at higher risk for a variety of other diseases, including premature death, heart disease, diabetes, high blood pressure, colon cancer, overweight, depression and anxiety. In fact, in its severe forms WM can shorten life expectancy. Psychological stress depression, anger and anxiety often accompany WM. People with WM may experience difficulty in coping with pain and disability which in turn can lead to a feeling of helplessness, lack of self-control and changes in self esteem and self image. Social well-being is also affected by decreased community involvement, difficulties in their work place and in sexual activities. These social problems are often aggravated by lack of understanding and empathy among family members, co-workers, employers, etc. Based on the references available in the Unani Classics the Central Council for Research in Unani Medicine formulated some simple new combination of drugs and subjected them to multicentric trials at Council's institutes. Prior to multicentric trial, preliminary screening was performed at the Regional Research Institute of Unani Medicine, Chennai in the year 1979 in which significant effects and clinical safety was observed. Later, the formulations were modified and multicentric study was undertaken along with some other combinations at Councils centres at Lucknow, Bhadrak, Mumbai, New Delhi, Srinagar and Bangalore. Multidimensional studies covering clinical, pathological, biochemical, physiological, herido-familial aspects in WM patients were studied besides Munzij and Mushil therapy and Hajamat (cupping). Since 1979, 40,000 patients were registered and treated at different centres of the Council. Out of these 8,000 patients fulfilling the research criteria were registered for study. Seven thousand five hundred and twenty-nine patients completed the study in different treatment groups. The cases were diagnosed on the basis of the sign and symptoms as per Unani classification taking in to consideration the involvement different humors, and the stage of the disease etc and correlated with the modern parameters 1987 revised ARA/ACR criteria for rheumatoid arthritis. The cases were classified as per standard criteria of possible, probable, definite and classical stages.

With a view to evaluate clinical safety of the drugs, liver and kidney function test including blood urea, serum creatinine, serum uric acid, serum total proteins, serum albumin, S.G.O.T. & S.G.P.T and serum cholesterol were done at baseline and at the end of study. Studies conducted in different treatment groups revealed significant therapeutic effects of the drug UNIM-301. The drug proved to possess disease modifying effects. If it is taken in early stage it can completely check further degeneration in joints and provide complete subsidence in signs and symptoms. It is effective in all stages of the disease. It cuts down the analgesic requirement. When given in the remission phase, it prolongs the remission phase. Thus it works as anti-inflammatory and analgesic. The drugs is safe in animals and human subject. The drug UNIM-302 has significant anti-inflammatory property when used in the form of Pashoya. The drug UNIM-304 has shown its effects in relieving pain, reducing inflammations and also imparts soothing effects.

MM therapy in conjunction with oral and local therapy of UNIM-301+ UNIM-302+UNIM-304 enhances the response and expedites the recovery. Significant improvement in the functional index of the patients in their routine work has been observed after completion of Munzij and Mushil therapy in chronic cases. Application of cupping proved effective in cases where big joints were involved but not in isolation. Cupping proved more effective when applied after completion MMT. It is concluded from the study that the combination of the drugs UNIM-301+UNIM-302+UNIM-304 is a complete safe and effective mode of treatment for WM.