| 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
|
|
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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
|
|
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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: ATISTHAULYAMÂ (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.
|
|
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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).
|