A COMPARATIVE CLINICAL TRIAL OF SIDDHAR YOGAM AND INJI CHOORANAM (INTERNAL) IN THE MANAGEMENT OF AZHAL KEEL VAYU (OSTEOARTHRITIS OF KNEE JOINT)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- The outcome of the trial is to access the reduction in the symptoms of knee osteoarthritis by WOMAC Scale (Western Ontario and McMaster Universities Osteoarthritis Index)
研究概览
简要总结
The aim of the study is to evaluate the therapeutic efficacy of Siddhar Yogam and Inji chooranam (internal)in the management of Azhal keel vayu(Osteoarthritis of knee joint). The objective of the study is to study the Siddhabasic principles relevant to the disease. The justification of the study is, the selected Yogapostures might focus on flexibility of the joint and increased blood flow inthat affected area, presumably by aligning knee joints. Many clinical researchstudies showed that the selected Yoga postures areeffective and safe in the management of Azhalkeel vayu (Osteoarthritis). The major ingredient in the formulation Inji chooranam is Inji (Zingiber officinale) is a kayakarpa (Rejuvination) medicine whichis effective in the management of old age problems like Osteoarthritis. Most of the other ingredients of Inji chooranam have anti-inflammatory, anti-oxidant, analgesic and anti-arthriticactivities. 90 selected patients will be divided randomly and grouped into 3 groups.
GROUP-A : 30 patients with Yogam only
GROUP-B : 30 patients with Inji chooranam only.
GROUP-C: 30 patients will be treated with Yogam and Inji chooranam.
Before starting thetreatment, purgation will be given with Meganathakuligai-2 tablets (130 mg) with warm water in empty stomach at earlymorning for balancing the deranged Uyir thathukaland advised to take rest on next day. The administration of trial drug Inji chooranam **(**internal) and Yogamtherapy will be started continuously for 45 days to the patients according tothe group.
Yogam procedureswill be taught and advised to practice continuously for 7 days. The enrolledpatients should visit the hospital once in 7 days upto 45 days. In each visit, clinicalassessment will be done and prognosis will be noted. Laboratory investigations willbe done before and aftertreatment. Radiological investigations will be done before enrolling thePatient into study. After completion of the trial period, the trial patientswill be followed for next two months to observe any recurrence of symptoms. The outcome of the trial will be accessed by WOMACScale (Western Ontario and McMaster Universities Osteoarthritis Index).
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
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •65years •Sex: male, female and transgender •Patients having the symptoms of pain, tenderness, stiffness, restricted movements, swelling and crepitation in knee joint. •Patient willing to give blood sample for laboratory investigation. •Patient willing to undergo radiological investigation (x-ray knee joint). •Patient willing to sign the informed consent.
排除标准
- •â€¢Psoriatic arthritis •Rheumatoid arthritis •Pregnancy and lactation •Coronary artery diseases •Diabetes mellitus •Uncontrolled hypertension •Recent surgery or trauma •Patient with any other serious illness.
结局指标
主要结局
The outcome of the trial is to access the reduction in the symptoms of knee osteoarthritis by WOMAC Scale (Western Ontario and McMaster Universities Osteoarthritis Index)
时间窗: 45 days
次要结局
未报告次要终点