A Randomised control trial to evaluate the effect of modified kala basti krama with vachadi gana in sthoulya with special reference to obesity.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- 62
研究概览
简要总结
A Randomised Control Trial to Evaluate the Effect of Modified Kala Basti Krama with Vachadi Gana in Sthoulya with Special Reference to Obesity”
Study Type:
Comparative study
Randomised Control Trial (RCT) – Parallel arm experimental design
Two groups:
Control Group: Standard Kala Basti Krama
Experimental Group: Modified Kala Basti Krama (3 consecutive Niruha followed by 1 Anuvasana)
Objective:
To evaluate the efficacy of modified Kala Basti krama using Vachadi Gana drugs in managing Sthoulya (obesity).
Assess both objective parameters (BMI, abdominal girth, waist-hip ratio) and subjective symptoms (like Chalasphik, Alasya, Atinidra, etc.)
Design Details:
Randomised, Controlled, Parallel-arm clinical trial
Duration: 32 days
Sample size: 31 patients
Inclusion: Age 20–50, BMI 25–34.9, fit for Basti
Exclusion: Pregnancy, severe illness, anorectal diseases
Treatment Details:
Vachadi Gana Kashaya used for Niruha Basti
Vachadi Gana Taila used for Anuvasana Basti
Total 16 Basti over 16 days (standard vs modified order)
Outcomes:
Change in BMI, waist-hip ratio, abdominal girth
Reduction in symptoms related to Kapha-Meda dushti
Safety and tolerability of modified basti schedule
Conclusion (Expected):
To determine whether modified Kala Basti Krama is more effective than traditional Kala Basti for managing Sthoulya, with fewer side effects and better results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •I) Patients of any gender, between age 20 to 50 years.
- •II) BMI between 25 to 34.9 kg/m2 .
- •III) Patients having signs and symptoms of sthoulya.
- •IV) Primary obesity (E66.0 of ICD-10 criteria) IV) patient is fit for basti.
排除标准
- •i) patient not fit for Basti karma.
- •i) Patients diagnosed with carcinoma, tuberculosis, HIV positive or any other life threatening condition.
- •ii)Patients having any ano-rectal diseases like fistula, fissure-in-ano, hemmorhoids.
- •iii) Pregnant and lactating women.
- •iv) Drug induced obesity like steroids and antipsychotic drugs.
结局指标
主要结局
62
时间窗: 4 to 5 weeks
次要结局
- Assessment of BMI , waist hip ratio, abdominal girth(4 to 5 weeks)
研究者
Vrushali Ramesh Gavit
Institute