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临床试验/CTRI/2023/10/058244
CTRI/2023/10/058244尚未招募2/3 期

Comparative Clinical Evaluation of the Efficacy of Medohar Guggulu and Weight Go in Sthaulya Roga (Obesity)

Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年10月14日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
3. Waist-Hip ratio

研究概览

简要总结

Thisstudy is a open label, double arm  comparative study, comparing the efficacy ofMedohar Guggulu each 500mg 2 tab twice daily after meal and Weight go each 640mg 2 tab daily after meal  in 40 patients with sthaulya rogathat will be conducted in Opd no. 13/14 in Patanjali ayurvedic hospital,Haridwar. Assessment will be done on the basis of subjective and objective parameter.

Route of administration- Oral route

Follow up- Follow up will be done to observe effects  of treatment or any adverse effect on the patient.

1st follow up- 1 month after commencement of treatment

2nd follow up- 1 month after the 1st follow up.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Inclusion criteria Patients between the age group of 18-60 years will be selected.
  • Patients having classical sign and symptoms of Sthaulya.
  • Patients of either gender will be selected.
  • Patients between BMI of 25-40 kg/m2 will be selected.

排除标准

  • Exclusion criteria Drug induced obesity.
  • Patients having serious diseases such as hepatic disease, cardiac disease, renal disease, pulmonary disease, history of thyroid , uncontrolled hypertension and Diabetes mellitus, other endocrine disorders will be excluded.
  • Other systemic diseases which intervenes with the course of treatment.
  • Patients having BMI > 40kg/m2 will be excluded.
  • Pregnant females and lactating women will be excluded.

结局指标

主要结局

3. Waist-Hip ratio

时间窗: 0day 30days 60 days

Subjective parameters-Grading will be done considering sign and symptoms of sthaulya-

时间窗: 0day 30days 60 days

1. Sphig chalatva (Pendlous movement of buttocks)

时间窗: 0day 30days 60 days

2. Udara chalatva (Pendulous movement of belly)

时间窗: 0day 30days 60 days

3. Stana chalatva (Pendulous movement of breast)

时间窗: 0day 30days 60 days

4. Swasa kasta (Breathlessness)

时间窗: 0day 30days 60 days

5. Janusandhishoola (Pain in both knee joints)

时间窗: 0day 30days 60 days

6. Atinidra (Excessive sleep)

时间窗: 0day 30days 60 days

7. Kshudaatimatram (Increased hunger)

时间窗: 0day 30days 60 days

8. Pipasaatiyogam (Excessive thirst)

时间窗: 0day 30days 60 days

9. Swedabadha (Excessive sweating)

时间窗: 0day 30days 60 days

10. Daurgandhya (Foul smell from body)

时间窗: 0day 30days 60 days

11. Daurbalya (Weakness)

时间窗: 0day 30days 60 days

Objective parameter-

时间窗: 0day 30days 60 days

1. Body weight

时间窗: 0day 30days 60 days

2. Body Mass Index

时间窗: 0day 30days 60 days

4. Measurement of circumference: Chest,abdomen,hip

时间窗: 0day 30days 60 days

is assessed

时间窗: 0day 30days 60 days

次要结局

  • Objective parameter-(1. Body weight)

研究者

发起方
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan
申办方类型
Private medical college

研究点 (1)

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