Clinical trial on over weight subjects
- Conditions
- Health Condition 1: E660- Obesity due to excess caloriesHealth Condition 2: E660- Obesity due to excess calories
- Registration Number
- CTRI/2022/08/044574
- Lead Sponsor
- Kerala Ayurveda Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1.Willing to give informed consent.
2.Healthy Indian male/ female volunteer aged between 18-65 years.
3.Must be able to adhere to the study visit schedule and other protocol requirements.
4.Willing to complete the questionnaires for the total duration of 90 days.
5.Body mass index (BMI) >25 kg/m2.
6.Agree not to use any medication (prescription and over the counter), including vitamins and minerals, during the course of this study
1.Those with severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.), heart disease (angina pectoris, myocardial infarction, heart failure, arrhythmia requiring treatment), or malignant tumors within the last six months. .
2.Patients with uncontrolled hypertension (blood pressure of 160/100 mmHg or higher, when measured after the subject rested for 10 minutes).
3.Diabetic patients with poor blood sugar control whose fasting blood sugar was 160 mg/dl or higher.
4.Those who were undergoing treatment for hypothyroidism or hyperthyroidism.
5.Those whose creatine level was more than twice the upper limit of the normal level set by the study center.
6.Those whose AST(GOT) or ALT(GPT) was more than three times the upper limit of the normal level set by the study center.
7.Those who complained of severe gastrointestinal symptoms, such as heartburn and indigestion.
8.Those who were on drugs that affect body weight within the last one month (absorption inhibitors and appetite suppressants, health foods/supplements related to obesity improvement, psychiatric drugs, such as antidepressants, beta-blockers, diuretics, contraceptives, steroids, and female hormones).
9.Those who participated in a commercial obesity program within the last three months.
10.Those who have participated in or had a plan to participate in other clinical trials within the last one month.
11.Heavy drinker (more than 500 ml per week with alcohol content >20%) since more than 3 years.
12.Those who quitted smoking within the last three months.
13.Those who were pregnant, lactating, or had a plan to become pregnant during the clinical trial period.
14.Those who showed allergic reactions to the ingredients of the food
15.Those who were deemed unsuitable for clinical trial participation by the investigator due to other reasons.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Body Mass Index (BMI) <br/ ><br>2.Body weight (Kg) <br/ ><br>3.Waist to Hip Ratio (WHR), waist circumference, hip circumference <br/ ><br>4.Feedback questionnaire <br/ ><br>Timepoint: Day 0 to Week 12
- Secondary Outcome Measures
Name Time Method Adverse eventsTimepoint: Day 0 to Week 12