CTRI/2022/08/044574招募中3 期
A prospective open label study to evaluate the safety, efficacy of KAL HS-03 in Weight Management of Obese and/or Overweight Subjects due to it Sthoulyahara and Medohara Properties
试验速览
- 阶段
- 3 期
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
排除标准
- •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.
研究者
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