A RANDOMIZED OPEN LABELLED CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF VASADI KWATHA IN THE MANAGEMENT OF VATARAKTA WITH SPECIAL REFERENCE TO GOUTY ARTHRITIS.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- REDUCTION IN THE LEVELS OF SERUM URIC ACID
研究概览
简要总结
THIS STUDY WAS PUT FORWARD TO EVALUATE THE EFFICACY OF VASADI KWATHA IN THE MANAGEMENT OF VATARAKTA WITH SPECIAL REFERENCE TO GOUTY ARTHRITIS IN COMPARISION WITH AMRITADI GUGGULU.
HYPOTHESIS:
- NULL HYPOTHESIS
H0 :-THE EFFICACY OF VASADI KWATHA IS EQUIVALENT TO AMRITADI GUGGULU IN THE MANAGEMENT OF VATARAKTA WITH SPECIAL REFERENCE TO GOUTY ARTHRITIS.
- ALTERNATE HYPOTHESIS
H1:-THE EFFICACY OF VASADI KWATHA IS GREATER THAN AMRITADI GUGGULU IN THE MANAGEMENT OF VATARAKTA WITH SPECIAL REFERENCE TO GOUTY ARTHRITIS.
H2:- THE EFFICACY OF VASADI KWATHA IS LESSER THAN AMRITADI GUGGULU IN THE MANAGEMENT OF VATARAKTA WITH SPECIAL REFERENCE TO GOUTY ARTHRITIS.
The study was completed with 30 subjects randomly allocated into 2 groups comprising15 subjects each. Subjects in Group A were treated with Vasadi Kwatha and Subjects in Group B were treated with Amritadi Guggulu for an intervention period of 30 days and follow up was for 15 days. Assessment was done on basis of both objective and subjective parameters on 0th day, 15th day, 30th day and 45th day.
On comparing the results between the groups, statistically non-significant results were obtained in all the parameters suggesting that, both Vasadi Kwatha and Amritadi Guggulu had equal effect in the management of Vatarakta. Thus, Null hypothesis is accepted, i.e, The efficacy of Vasadi kwatha is equivalent to Amritadi Guggulu in the management of Vatarakta with special reference to Gouty Arthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Open Label
入排标准
- 年龄范围
- 21.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •SUBJECTS FULFILLING CRITERIAS OF AMERICAN COLLEGE OF RHEUMATOLOGY 1977 AND SUBJECTS WITH INCREASED LEVEL OF SERUM URIC ACID OF 7mg/dl to 10mg/dl IN MALE AND 6mg/dl to 10mg/dl IN FEMALE.
排除标准
- •SUBJECTS DIAGNOSED WITH OTHER INFLAMMATORY AND DEGENERATIVE JOINT DISEASE
- •SUBJECTS WITH HISTORY OF TRAUMA, FRACTURE JOINT, SURGICAL OR DIAGNOSTIC INTERVENTION WITH REFERENCE TO THE AFFECTED JOINT(S) IN PAST 1 YEAR.
- •PREGNANT AND LACTATING WOMEN
- •SUBJECTS WITH ANY UNCONTROLLED SYSTEMIC ILLNESS INCLUDING DIABETES MELLITUS, HYPERTENSION.
- •SUBJECTS WITH VATARAKTA WITH SPECIAL REFERENCE TO GOUTY ARTHRITIS PRESENTING WITH COMPLICATION INCLUDING JOINT DEFORMITIES.
- •ANY OTHER CONDITION INTERFERING THE COURSE OF TREATMENT.
结局指标
主要结局
REDUCTION IN THE LEVELS OF SERUM URIC ACID
时间窗: 30TH DAY, 45TH DAY
次要结局
- REDUCTION IN THE CLASSICAL SIGNS AND SYMPTOMS OF VATARAKTA(REDUCTION IN THE SIGNS AND SYMPTOMS OF VATARAKTA ON 15th day, 30th DAY and 45th day)