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
- Phase 3 4
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 3.Waist to Hip Ratio (WHR), waist circumference, hip circumference
研究概览
简要总结
Ancient ayurvedic herbs wereknown for its various properties that are good for digestive health, diseaseprevention, detoxification and removing unwanted body fat. Harad also is knownas haritaki is the name of the dried fruit of the Terminalia Chebula tree. Consumingharitaki can increase nutrient absorption, cleansing of the colon and a healthyintestinal environment. This will also reduce the cravings for junk food, andhave a positive effect on losing weight. Chewing raw hard fruit can enhancedigestive power immensely and increases the rate of metabolism in the body.Gastrointestinal health is improved due to the ability to absorb minerals,vitamins, and antioxidants. They clean the intestinal tract and purify theblood. Researchers have said that using Terminalia chebula for metabolicsyndrome has shown significant intestinal motility- enhancing effect and can bea useful aid in keeping bowel movements regular..
Oral feeding of the aqueous E.officinalis extract (20 mg/kg) to HFD-induced obese rats for a period of 42days resulted in significant reduction in body weight gain, insulin, leptin,lipids as compared to rats fed HFD alone. Further, the extract also showedsignificant increase in high density lipoprotein (HDL-C) levels. Discussion andconclusions These results show that aqueous E. officinalis extract possesssignificant anti-obesity potential.
Curcuma longa, curcumin, intakeamong patients with metabolic syndrome and related disorders was correlatedwith a significant reduction in BMI, weight, WC, and leptin, and a significantincrease in adiponectin levels, but did not affect HR [6]. There are some datathat have shown that some spices, including curcumin may play a key function inthe management of overweight individuals. Curcumin is a bioactive polyphenolcomponent which is found in turmeric rhizomes and is commonly referred to asdiferuloylmethane [7]. Clinical trials of curcumin on weight- and body massindex (BMI)-lowering effect have not been systematically evaluated, and theresults are inconsistent.
A few medicinal herbs have aplace to mention in the ayurvedic books for their individual anti-inflammatoryactivity. The present study is aimed to see a combination of a few such herbalmedicinal plants for their efficacy in the weight management (both in overweight and obese).
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
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/m
- •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.
结局指标
主要结局
3.Waist to Hip Ratio (WHR), waist circumference, hip circumference
时间窗: Day 0 to Week 12
2.Body weight (Kg)
时间窗: Day 0 to Week 12
1.Body Mass Index (BMI)
时间窗: Day 0 to Week 12
4.Feedback questionnaire
时间窗: Day 0 to Week 12
次要结局
- Adverse events(Day 0 to Week 12)