A pilot study to evaluate the therapeutic efficacy of Siddha herbo mineral formulations Chandamarutha Chenduram (Internal) and Poonaga thylam (External) in the treatment of "Uthiravatha suronitham" (Rheumatoid arthritis)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Universal Pain Assessment Scale (0-10)
研究概览
简要总结
This study is a single arm clinical trial evaluating the efficacy of siddha medicine, one of the indian systems of medicine, as an effective intervention strategy for the disease Uthiravatha Suronitham.
Uthiravatha Suronitham
This is one of 80 types of Vatha diseases mentioned in Siddha literatures. Symptoms of the disease Uthiravatha Suronitham of Siddha pathology can be correlated to the disease Rheumatoid arthritis in modern.
Word about drug
The medicines Chandamarutha Chenduram (Internal drug) and Poonaga thylam (External drug), which are unique herbo mineral combinations are selected from authenticated Siddha text books. The drug Chandamarutha Chenduram is administered at a dose of 65 mg orally twice a day with palm jaggery after food and the drug Poonaga thylam administered externally over the affected part to 40 patients included as per inclusion criteria for a period of 48 days with no further administration thereafter.
Purpose of study
The primary outcome measure of the siddha medicine is reduction in pain which is the most difficult part of this disease which is to be assessed by Universal pain assessment scale before and after treatment. As there has been no evidence of clinical trial conducted with the above mentioned drugs till today the investigator proposed this trial.
RESULTS
- Clinical study revealed that out of 40 cases, 38 (95%) cases have shown reduction in pain.
- Regarding HAQ questionnaire ( For assessment of restriction of movements) the score was improved in 97.5% cases. There was also reduction in other clinical symptoms after the treatment.
- The toxicity studies conducted (Acute and Long term toxicity studies - As per WHO Guidelines) revealed that the trial drug was safe even at 23.4mg/animal (Ten times that of normal dose). There were no abnormalities found in the blood and histopathological investigation of animals. Hence it can be reasonably assumed that the drug is safe for humans.
- There was significant reduction in the elevated lab parameters (C-Reactive protein, Rheumatoid factor, ESR etc) after the treatment indicating the control of the disease.
- There were no adverse reaction complained during the trial.
- A multicentric trial with large number of patients would throw more light on the efficacy of this line of treatment and mainstreaming with public health care activities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 15.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Age: 15-60 years, Sex: Both male and female Patients having the symptoms of arthritis of three or more joints, symmetrical joint involvement, swelling especially in inter phalangeal joints, morning stiffness of joints, low grade fever, serum rheumatoid factor both positive and negative, anorexia & mental stress Patients who are willing to give radiological investigation and provide blood for lab investigation Patient willing to sign informed consent stating that he/she will conscientiously stick to the treatment during 48 days but can opt out of the trial of his/her own conscious discretion.
排除标准
- •Cardiac disease Hypertension Diabetes mellitus Use of narcotic drugs Pregnancy and lactation History of trauma Tuberculosis Bronchial asthma Any other serious illness.
结局指标
主要结局
Universal Pain Assessment Scale (0-10)
时间窗: before and after treatment
次要结局
- Reduction in other clinical symptoms(Before and after treatment)
- Restricted movement assessment scale(before and after)
- Hb & ESR variation(Before and after)
- RA factor & CRP Variation(Before and After treatment)