Evaluation of the safety and efficacy of Triphala and Trimad in Obese and overweight individuals: A pilot clinical study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- weight loss
研究概览
简要总结
Introduction and purpose of the study:
Obesity is a medical condition which occurs due to excess storage of fat. In recent times it has become common problem in all age groups. Diet and exercise are the primary way of obesity prevention but with short term benefits. Conventional drugs cause various side effects and expensive too. Obesity control is important to avoid other complications like cardiovascular disorder, hypertension, GI disorder etc. In case of very high weight, surgery is recommended but it is painful is not cost effective.
Triphala and Trimad are Ayurvedic herbal formulations known for their beneficial effects mentioned in Ayurveda. Triphala is commonly used for various medical problems and multi-functional. Trimad is known for boosting immunity, stop fat deposition and act as appetizer. Their efficacy in weight management has been proved in some modern research. Hence the present study has been planned to evaluate the safety and efficacy of Triphala and Trimad for obesity control and associated benefits to it.
Objectives of the Study:
i. To evaluate the effect Triphala and Trimad on weight management in obese and overweight individuals
ii. To evaluate the effect of Triphala and Trimad in body fat composition and inches loss
Duration of participation in the Study: After obtaining informed consent from participate in the study, they have to visit study site Vishwanand kendra after every 15 days till the end of study for 120 days. We would take a written consent for the purpose.
Study Procedures and Methods:
After screening and categorizing participants as overweight and obese as per BMI drug will be dispensed.
During this meeting (Day 0), detail history with respect to present complaints and any other significant medical/surgical illnesses will be taken. Participant will undergo clinical examination to check for weight, height (once), circumference (waist, hip) to assess the BMI, WHR. Following this, a questionnaire will be administered to assess quality of life and eating behavior. Both Participant and study physician will not be aware of the drug which patients will receive till the end of the treatment.
On every 15 days, participants will undergo clinical examination, like weight, height, and circumference and also administered questionnaire. They will be interrogated about change in your symptoms, and unwanted symptom/s developed after start of the therapy, if any.
All the investigations carried out on Day 0 will be repeated every 15 days of visit. The analysis of samples will help in judging the improvement in weight reduction after taking Triphala or Trimad and placebo effect.
Results and outcome:
Theparameters evaluated were anthropometric profile (weight, Body Mass Index,circumferential measures viz. waist, hip, neck, mid-arm, mid-thigh) along with bodycomposition analysis (Fat%, visceral fat %, muscle mass, resting metabolism,body age). The formulations have showed improvement in all the parameters significantly morethan placebo. Interestingly, the patients treated with formulation showed minimal weightgain after stopping the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Obesity (BMI ≥30.0 kg/m2); or overweight (BMI ≥25.0 kg/m2) with controlled co-morbid dyslipidemia and/or hypertension and/or type 1 or type 2 diabetes 2.Stable body weight (less than 5 kg self-reported change during the previous 3 months) 3.Age ≥18 years to ≤60 years 4.Willing to give Informed consent before any trial-related activity takes place.
排除标准
- •1.Known case of any other endocrinological disorders 2.Current or history of treatment with medications that may cause significant weight gain, within 3 months prior to screening, including oAllopathic medicines: systemic corticosteroids (except for a short course of treatment, i.e. 7−10 days),tri-cyclic antidepressants, atypical antipsychotic and mood stabilizers (e.g. imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid and its derivatives, and lithium) oAyurvedic medicines: Shatavari, Ashwagandha, Bala etc.
- •3.History of use/ currently using dietary supplements, over-the-counter medications or below mentioned Allopathic /Ayurvedic medicines one month before screening oAllopathic medicines: pramlintide, sibutramine, orlistat, zonisamide, topiramate, phentermine, or metformin (either by prescription or as part of a clinical trial) oAyurvedic medicines: Guggulu, Trikatu, Triphala, Trimada, Shilajatu and/ or any other ayurvedic medicine (causing weight reduction) either individually or as a part of any other formulation 4.Current participation (past one month) in an organized weight reduction program 5.Participants with a history of major depressive or other severe psychiatric disorders or an eating disorder 6.Surgery scheduled for the trial duration period, except for minor surgical procedures, at the discretion of the investigator 7.Females of child-bearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods.
结局指标
主要结局
weight loss
时间窗: every fifteen day from day of recruitment
次要结局
- body fat monitor parameters, inches loss(every fifteen day from day of recruitment)