CTRI/2024/07/071260尚未招募3 期
A Randomized Comparative Clinical Study To Evaluate The Efficacy Of Chavyadi Churna With And Without Lekhana Basti In The Management Of Sthaulya (Obesity)
Kunwar Shekhar Vijendra Ayurved Medical College And Research Centre Shobhit University1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2024年8月15日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Reduction in sign and symptoms of staulya
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. The clinical research format will be prepared and validated. Prior to the study, approval will be taken from IEC, KSVAMC & RC, SU GANGOH, SAHARANPUR and CTRI registration will be done after selection, each participant will be tested individually and selected according to the selection criteria. They are divided into two groups a trial is a parallel group, randomized, open label trial. It will include 45v days treatment period and an every 15th day follow up period
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients willing to sign the consent form.
- •2.Patients having clinical features of obesity.
- •3.Patients between the age group of 18-50 years of either sex.
- •4.Body mass index (BMI) from 30-39.9 i.e. Class 1 and class 2 obesity.
- •5.Waist Circumference greater than 102 cm (40 in) in men and greater than 88 cm (35in) in women.
排除标准
- •1.Patients in the age group of less than 18 years and more than 50 years will not be included for the present study.
- •2.Patients not willing for clinical trial.
- •3.Obese patients suffering from obesity due to hormonal imbalance, hypothyroidism, cardiovascular diseases, hemiplegia, associated with severe hypertension(160/110 and higher), liver and kidney disease, uncontrolled diabetes mellitus (HbA1c 6.5% and higher), pregnant and lactating mothers.
- •and from other such diseases in which the patient cannot do his routine physical activities will be excluded.
- •4.Very obese patients having BMI 40 or more than 40 will be excluded from the present study.
- •Patient under another clinical trial.
- •5.Patient on steroids therapy and oral contraceptive therapy.
- •6.Patients of Ajeerna, Ati Snigdha, Peeta Sneha, Utklishta Dosha, Alpa Agni.
- •Yana Klanta, Ati Durbala, Kshudaarta, Trishnarta, Shramaarta, Ati Krusha, Bhuktabhakta, Peeta Udaka, Vamita.
- •Virikta, Kurta Nasya Karma, Kruddha, Bheeta, Kasa Prasakia, Hikka Prasakta, Dakodara, Aadhmana, Visuchika, Ama Dosha.
- •Kushta, Arsha, Pandu, Unmada, Shopha.
- •7.Patients allergic to the contents of Basti.
结局指标
主要结局
Reduction in sign and symptoms of staulya
时间窗: Reduction in sign and symptoms of staulya
次要结局
- 1.To observe adevrse effects if any.(2. Cost effective treatment)
研究者
Dr Parul Saini
Kunwar Shekhar Vijendra Ayurved Medical College And Research Centre, Shobhit University
研究点 (1)
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