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CTRI Number  CTRI/2022/08/044574 [Registered on: 02/08/2022] Trial Registered Prospectively
Last Modified On: 03/12/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Clinical trial on over weight subjects  
Scientific Title of Study
Modification(s)  
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 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Version 1.0 Dated 01 July 2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anjali Jayantrao Raichur 
Designation  Principal investigator  
Affiliation  Kerala Ayurveda Wellness Center 
Address  #573 20th Main Road, next to BIBA showroom, Koramangala 8th Block, Koramangala, Bengaluru, Karnataka

Bangalore
KARNATAKA
5600095
India 
Phone  9880866668   
Fax    
Email  dranjali@keralaayurveda.biz  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sarala Samuel  
Designation  Vice president -Research and Development  
Affiliation  Kerala Ayurveda Ltd. 
Address  Athani Post, Aluva, Ernakulam District, Kerala – India

Ernakulam
KERALA
683585
India 
Phone  9895517764   
Fax    
Email  sarala@keralaayurveda.biz  
 
Details of Contact Person
Public Query
 
Name  Dr Sarala Samuel  
Designation  Vice president -Research and Development  
Affiliation  Kerala Ayurveda Ltd. 
Address  Athani Post, Aluva, Ernakulam District, Kerala – India


KERALA
683585
India 
Phone  9895517764   
Fax    
Email  sarala@keralaayurveda.biz  
 
Source of Monetary or Material Support  
Kerala Ayurveda Limited Athani Post, Aluva,Ernakulam District, Kerala – 683585, India  
 
Primary Sponsor  
Name  Kerala Ayurveda Limited 
Address  Athani Post, Aluva,Ernakulam District, Kerala – 683585, India 
Type of Sponsor  Other [Ayurveda and wellness ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anjali Jayantrao Raichur  Kerala Ayurveda Wellness Center  #573 20th Main Road, Ground floor Room no 2 next to BIBA showroom, Koramangala 8th Block, Koramangala, Bengaluru, Karnataka 5600095
Bangalore
KARNATAKA 
9880866668

dranjali@keralaayurveda.biz 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Venkateshwara Hospitals Ethics commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E660||Obesity due to excess calories, (2) ICD-10 Condition:E660||Obesity due to excess calories. Ayurveda Condition: ATISTHAULYAM (KEVALA-KAPHA),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  KAL HS-03 Arishtam  Dosage : Arishtam Dose: 60 ml per day (Morning 30 ml and evening 30 ml after food) Duration: 12 weeks 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  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
 
 
ExclusionCriteria 
Details  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.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Body Mass Index (BMI)
2. Body weight (Kg)
3. Waist to Hip Ratio (WHR), waist circumference, hip circumference
4. Feedback questionnaire
 
Day 0 to Week 12 
 
Secondary Outcome  
Outcome  TimePoints 
Adverse events   Day 0 to Week 12 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   02/08/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Ancient ayurvedic herbs were known for its various properties that are good for digestive health, disease prevention, detoxification and removing unwanted body fat. Harad also is known as haritaki is the name of the dried fruit of the Terminalia Chebula tree. Consuming haritaki can increase nutrient absorption, cleansing of the colon and a healthy intestinal environment. This will also reduce the cravings for junk food, and have a positive effect on losing weight. Chewing raw hard fruit can enhance digestive 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 the blood. Researchers have said that using Terminalia chebula for metabolic syndrome has shown significant intestinal motility- enhancing effect and can be a 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 42 days resulted in significant reduction in body weight gain, insulin, leptin, lipids as compared to rats fed HFD alone. Further, the extract also showed significant increase in high density lipoprotein (HDL-C) levels. Discussion and conclusions These results show that aqueous E. officinalis extract possess significant anti-obesity potential.

 

Curcuma longa, curcumin, intake among patients with metabolic syndrome and related disorders was correlated with a significant reduction in BMI, weight, WC, and leptin, and a significant increase in adiponectin levels, but did not affect HR [6]. There are some data that have shown that some spices, including curcumin may play a key function in the management of overweight individuals. Curcumin is a bioactive polyphenol component which is found in turmeric rhizomes and is commonly referred to as diferuloylmethane [7]. Clinical trials of curcumin on weight- and body mass index (BMI)-lowering effect have not been systematically evaluated, and the results are inconsistent.

 

A few medicinal herbs have a place to mention in the ayurvedic books for their individual anti-inflammatory activity. The present study is aimed to see a combination of a few such herbal medicinal plants for their efficacy in the weight management (both in over weight and obese).


 
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