Health Condition 1: E660- Obesity due to excess calories Health Condition 2: E660- Obesity due to excess calories
Conditions
Interventions
Intervention1: KAL HS-03 Arishtam: Dosage : Arishtam Dose: 60 ml per day (Morning 30 ml and evening 30 ml after food) Duration: 12 weeks
Control Intervention1: Nil: Nil
Sponsors
Kerala Ayurveda Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Body Mass Index (BMI) 2.Body weight (Kg) 3.Waist to Hip Ratio (WHR), waist circumference, hip circumference 4.Feedback questionnaire Timepoint: Day 0 to Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse eventsTimepoint: Day 0 to Week 12 | — |
Countries
India
Contacts
Public ContactDr Sarala Samuel
Kerala Ayurveda Ltd.
Outcome results
None listed