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临床试验/CTRI/2025/03/083224
CTRI/2025/03/083224尚未招募Phase 3 4

Evaluation of Comparative Efficacy of Gomutra Haritaki Yog and Atorvastatin in the management of Obesity-(Sthoulya)

Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年4月1日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
To asses the Efficacy of Gomutra Haritaki Yog and Atorvastatin over Weight BMI weight in kg per height in metre square Hip Waist ratio Lipid Profile

研究概览

简要总结

the volunteers will be informed about the study protocol. Willing participants will be randomly selected as per computer generated table. Clinical research format will be prepared and validated. Prior to the study approval will be taken from IEC, MGACHRC, Salod (H) Wardha and CTRI registration will be done. After selection, each participant will be tested individually and selected according to selection criteria. They are divided into two groups the trial is a two arm parallel group, randomized, single blind clinical, standard controlled trial. it will include a 2 months treatment period and at 15th day , 1month ,2 month follow up period

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 40.00 Year(s)(—)
性别
All

入选标准

  • Patient of obesity will be recruited as per ICD Criteria for Obesity Subjects willing to participate in the study and sign the written informed consent Subjects between age group of 20 to 40 years of either sex Subjects having BMI more than or equal to 30 to 40 kg per m2.

排除标准

  • Known case of Hypothyroidism Diabetes mellitus Cardiovascular Renal Disorder and Drug induced Obesity etc Pregnant lady and Lactating mother Any other illness developed during treatment.

结局指标

主要结局

To asses the Efficacy of Gomutra Haritaki Yog and Atorvastatin over Weight BMI weight in kg per height in metre square Hip Waist ratio Lipid Profile

时间窗: At 0 days ,15 days , 1 month, 2 month

次要结局

  • Comparison and assesment of Efficacy of Gomutra Haritaki Yog and Atorvastatin in Weight BMI weight in kg per height in metre square Hip Waist ratio Lipid Profile

研究者

发起方
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Sakshi Krushnaji Mute

Mahatma Gandhi Ayurved College Hospital and Research Center

研究点 (1)

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