A COMPARATIVE OPEN LABELLED STUDY OF GUDUCHI KSHEER TAIL AND TIL TAILMATRA BASTI IN THE MANAGEMENT OF VATARAKTA WITH SPECIAL REFERENCE TO GOUT
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- The primary outcome measure will be rated using the
研究概览
简要总结
In this modern era, the incidence of patients suffering from Vatarakta are increasing on a steady pace. Vatarakta is a metabolic disorder where pain is pre dominant symptom , which disturbs day today life of the affected individuals .Considering the clinical presentation and textual references of Vatarakta , it can be correlated with Gout explained in modern medicine.
As panchakarma is the classical and effective cleansing modality to break down path-physiology of gout ,The simplest type of basti matra basti as a panchakarma selected for the present study .There are various formulations mentioned in Samhitas among which I have selected Guduchi Ksheer Tail and til tail as Matra Basti in Gout.
To compare the effect of guduchi ksheer tail and til tail matra basti in Vatarakta in terms of serum uric acid levels .
Is there any difference in the effects of guduchi ksheer tail and til tail matra basti ?
There is significant difference in the effects of Guduchi Ksheer Tail and Til Tail matra basti .
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients presenting features as Vatarakta as per text 2) Irrespective of sex.
- •Willing to participate.
排除标准
- •Pregnancy and Lactation 2) patients of severe anorectal disorders 3) Major systemic diseases.
- •All arthritic conditions other than Vatarakta 5) chronic renal disorders.
结局指标
主要结局
The primary outcome measure will be rated using the
时间窗: The primary outcome measure will be rated using the | Assessment criteria | A) Subjective (Day 0, Day 16, Day30) | Visual analogue scale (1to 10) | Presentation at affected joints | 1. Swelling (Shotha) | 2. Pain (Pida, Daha,Toda) | 3. Stiffness (Kathinya) | 4. Tenderness (Sparshasahatva) | 5. Functional score (Ability to perform joint functions) | Objective Criteria | Following objective criteria will be assessed on day 0, day16, day30 | Lab investigation | a. Serum uric acid level | b. Erythrocyte Sedimentation Rate (By Win Trobe Method) | c. Complete Blood Count | Health assessment questionnaire disability index (H A Q DI
Assessment criteria
时间窗: The primary outcome measure will be rated using the | Assessment criteria | A) Subjective (Day 0, Day 16, Day30) | Visual analogue scale (1to 10) | Presentation at affected joints | 1. Swelling (Shotha) | 2. Pain (Pida, Daha,Toda) | 3. Stiffness (Kathinya) | 4. Tenderness (Sparshasahatva) | 5. Functional score (Ability to perform joint functions) | Objective Criteria | Following objective criteria will be assessed on day 0, day16, day30 | Lab investigation | a. Serum uric acid level | b. Erythrocyte Sedimentation Rate (By Win Trobe Method) | c. Complete Blood Count | Health assessment questionnaire disability index (H A Q DI
A) Subjective (Day 0, Day 16, Day30)
时间窗: The primary outcome measure will be rated using the | Assessment criteria | A) Subjective (Day 0, Day 16, Day30) | Visual analogue scale (1to 10) | Presentation at affected joints | 1. Swelling (Shotha) | 2. Pain (Pida, Daha,Toda) | 3. Stiffness (Kathinya) | 4. Tenderness (Sparshasahatva) | 5. Functional score (Ability to perform joint functions) | Objective Criteria | Following objective criteria will be assessed on day 0, day16, day30 | Lab investigation | a. Serum uric acid level | b. Erythrocyte Sedimentation Rate (By Win Trobe Method) | c. Complete Blood Count | Health assessment questionnaire disability index (H A Q DI
Visual analogue scale (1to 10)
时间窗: The primary outcome measure will be rated using the | Assessment criteria | A) Subjective (Day 0, Day 16, Day30) | Visual analogue scale (1to 10) | Presentation at affected joints | 1. Swelling (Shotha) | 2. Pain (Pida, Daha,Toda) | 3. Stiffness (Kathinya) | 4. Tenderness (Sparshasahatva) | 5. Functional score (Ability to perform joint functions) | Objective Criteria | Following objective criteria will be assessed on day 0, day16, day30 | Lab investigation | a. Serum uric acid level | b. Erythrocyte Sedimentation Rate (By Win Trobe Method) | c. Complete Blood Count | Health assessment questionnaire disability index (H A Q DI
Presentation at affected joints
时间窗: The primary outcome measure will be rated using the | Assessment criteria | A) Subjective (Day 0, Day 16, Day30) | Visual analogue scale (1to 10) | Presentation at affected joints | 1. Swelling (Shotha) | 2. Pain (Pida, Daha,Toda) | 3. Stiffness (Kathinya) | 4. Tenderness (Sparshasahatva) | 5. Functional score (Ability to perform joint functions) | Objective Criteria | Following objective criteria will be assessed on day 0, day16, day30 | Lab investigation | a. Serum uric acid level | b. Erythrocyte Sedimentation Rate (By Win Trobe Method) | c. Complete Blood Count | Health assessment questionnaire disability index (H A Q DI
1. Swelling (Shotha)
时间窗: The primary outcome measure will be rated using the | Assessment criteria | A) Subjective (Day 0, Day 16, Day30) | Visual analogue scale (1to 10) | Presentation at affected joints | 1. Swelling (Shotha) | 2. Pain (Pida, Daha,Toda) | 3. Stiffness (Kathinya) | 4. Tenderness (Sparshasahatva) | 5. Functional score (Ability to perform joint functions) | Objective Criteria | Following objective criteria will be assessed on day 0, day16, day30 | Lab investigation | a. Serum uric acid level | b. Erythrocyte Sedimentation Rate (By Win Trobe Method) | c. Complete Blood Count | Health assessment questionnaire disability index (H A Q DI
2. Pain (Pida, Daha,Toda)
时间窗: The primary outcome measure will be rated using the | Assessment criteria | A) Subjective (Day 0, Day 16, Day30) | Visual analogue scale (1to 10) | Presentation at affected joints | 1. Swelling (Shotha) | 2. Pain (Pida, Daha,Toda) | 3. Stiffness (Kathinya) | 4. Tenderness (Sparshasahatva) | 5. Functional score (Ability to perform joint functions) | Objective Criteria | Following objective criteria will be assessed on day 0, day16, day30 | Lab investigation | a. Serum uric acid level | b. Erythrocyte Sedimentation Rate (By Win Trobe Method) | c. Complete Blood Count | Health assessment questionnaire disability index (H A Q DI
3. Stiffness (Kathinya)
时间窗: The primary outcome measure will be rated using the | Assessment criteria | A) Subjective (Day 0, Day 16, Day30) | Visual analogue scale (1to 10) | Presentation at affected joints | 1. Swelling (Shotha) | 2. Pain (Pida, Daha,Toda) | 3. Stiffness (Kathinya) | 4. Tenderness (Sparshasahatva) | 5. Functional score (Ability to perform joint functions) | Objective Criteria | Following objective criteria will be assessed on day 0, day16, day30 | Lab investigation | a. Serum uric acid level | b. Erythrocyte Sedimentation Rate (By Win Trobe Method) | c. Complete Blood Count | Health assessment questionnaire disability index (H A Q DI
4. Tenderness (Sparshasahatva)
时间窗: The primary outcome measure will be rated using the | Assessment criteria | A) Subjective (Day 0, Day 16, Day30) | Visual analogue scale (1to 10) | Presentation at affected joints | 1. Swelling (Shotha) | 2. Pain (Pida, Daha,Toda) | 3. Stiffness (Kathinya) | 4. Tenderness (Sparshasahatva) | 5. Functional score (Ability to perform joint functions) | Objective Criteria | Following objective criteria will be assessed on day 0, day16, day30 | Lab investigation | a. Serum uric acid level | b. Erythrocyte Sedimentation Rate (By Win Trobe Method) | c. Complete Blood Count | Health assessment questionnaire disability index (H A Q DI
5. Functional score (Ability to perform joint functions)
时间窗: The primary outcome measure will be rated using the | Assessment criteria | A) Subjective (Day 0, Day 16, Day30) | Visual analogue scale (1to 10) | Presentation at affected joints | 1. Swelling (Shotha) | 2. Pain (Pida, Daha,Toda) | 3. Stiffness (Kathinya) | 4. Tenderness (Sparshasahatva) | 5. Functional score (Ability to perform joint functions) | Objective Criteria | Following objective criteria will be assessed on day 0, day16, day30 | Lab investigation | a. Serum uric acid level | b. Erythrocyte Sedimentation Rate (By Win Trobe Method) | c. Complete Blood Count | Health assessment questionnaire disability index (H A Q DI
Objective Criteria
时间窗: The primary outcome measure will be rated using the | Assessment criteria | A) Subjective (Day 0, Day 16, Day30) | Visual analogue scale (1to 10) | Presentation at affected joints | 1. Swelling (Shotha) | 2. Pain (Pida, Daha,Toda) | 3. Stiffness (Kathinya) | 4. Tenderness (Sparshasahatva) | 5. Functional score (Ability to perform joint functions) | Objective Criteria | Following objective criteria will be assessed on day 0, day16, day30 | Lab investigation | a. Serum uric acid level | b. Erythrocyte Sedimentation Rate (By Win Trobe Method) | c. Complete Blood Count | Health assessment questionnaire disability index (H A Q DI
Following objective criteria will be assessed on day 0, day16, day30
时间窗: The primary outcome measure will be rated using the | Assessment criteria | A) Subjective (Day 0, Day 16, Day30) | Visual analogue scale (1to 10) | Presentation at affected joints | 1. Swelling (Shotha) | 2. Pain (Pida, Daha,Toda) | 3. Stiffness (Kathinya) | 4. Tenderness (Sparshasahatva) | 5. Functional score (Ability to perform joint functions) | Objective Criteria | Following objective criteria will be assessed on day 0, day16, day30 | Lab investigation | a. Serum uric acid level | b. Erythrocyte Sedimentation Rate (By Win Trobe Method) | c. Complete Blood Count | Health assessment questionnaire disability index (H A Q DI
Lab investigation
时间窗: The primary outcome measure will be rated using the | Assessment criteria | A) Subjective (Day 0, Day 16, Day30) | Visual analogue scale (1to 10) | Presentation at affected joints | 1. Swelling (Shotha) | 2. Pain (Pida, Daha,Toda) | 3. Stiffness (Kathinya) | 4. Tenderness (Sparshasahatva) | 5. Functional score (Ability to perform joint functions) | Objective Criteria | Following objective criteria will be assessed on day 0, day16, day30 | Lab investigation | a. Serum uric acid level | b. Erythrocyte Sedimentation Rate (By Win Trobe Method) | c. Complete Blood Count | Health assessment questionnaire disability index (H A Q DI
a. Serum uric acid level
时间窗: The primary outcome measure will be rated using the | Assessment criteria | A) Subjective (Day 0, Day 16, Day30) | Visual analogue scale (1to 10) | Presentation at affected joints | 1. Swelling (Shotha) | 2. Pain (Pida, Daha,Toda) | 3. Stiffness (Kathinya) | 4. Tenderness (Sparshasahatva) | 5. Functional score (Ability to perform joint functions) | Objective Criteria | Following objective criteria will be assessed on day 0, day16, day30 | Lab investigation | a. Serum uric acid level | b. Erythrocyte Sedimentation Rate (By Win Trobe Method) | c. Complete Blood Count | Health assessment questionnaire disability index (H A Q DI
b. Erythrocyte Sedimentation Rate (By Win Trobe Method)
时间窗: The primary outcome measure will be rated using the | Assessment criteria | A) Subjective (Day 0, Day 16, Day30) | Visual analogue scale (1to 10) | Presentation at affected joints | 1. Swelling (Shotha) | 2. Pain (Pida, Daha,Toda) | 3. Stiffness (Kathinya) | 4. Tenderness (Sparshasahatva) | 5. Functional score (Ability to perform joint functions) | Objective Criteria | Following objective criteria will be assessed on day 0, day16, day30 | Lab investigation | a. Serum uric acid level | b. Erythrocyte Sedimentation Rate (By Win Trobe Method) | c. Complete Blood Count | Health assessment questionnaire disability index (H A Q DI
c. Complete Blood Count
时间窗: The primary outcome measure will be rated using the | Assessment criteria | A) Subjective (Day 0, Day 16, Day30) | Visual analogue scale (1to 10) | Presentation at affected joints | 1. Swelling (Shotha) | 2. Pain (Pida, Daha,Toda) | 3. Stiffness (Kathinya) | 4. Tenderness (Sparshasahatva) | 5. Functional score (Ability to perform joint functions) | Objective Criteria | Following objective criteria will be assessed on day 0, day16, day30 | Lab investigation | a. Serum uric acid level | b. Erythrocyte Sedimentation Rate (By Win Trobe Method) | c. Complete Blood Count | Health assessment questionnaire disability index (H A Q DI
Health assessment questionnaire disability index (H A Q DI
时间窗: The primary outcome measure will be rated using the | Assessment criteria | A) Subjective (Day 0, Day 16, Day30) | Visual analogue scale (1to 10) | Presentation at affected joints | 1. Swelling (Shotha) | 2. Pain (Pida, Daha,Toda) | 3. Stiffness (Kathinya) | 4. Tenderness (Sparshasahatva) | 5. Functional score (Ability to perform joint functions) | Objective Criteria | Following objective criteria will be assessed on day 0, day16, day30 | Lab investigation | a. Serum uric acid level | b. Erythrocyte Sedimentation Rate (By Win Trobe Method) | c. Complete Blood Count | Health assessment questionnaire disability index (H A Q DI
次要结局
- secondary outcomes were health assestment questionnarire disability index subscale (pain , Stiffness etc )also safety ( adverse events and serious adverse events ) are assessed.(secondary outcomes will be assedssed at base line,0 , 16 and 30 day)
研究者
Dr Subodh Chandrakant Patil
A P M s Ayurved College Sion Mumbai