| CTRI Number |
CTRI/2024/10/075525 [Registered on: 18/10/2024] Trial Registered Prospectively |
| Last Modified On: |
16/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative Clinical Study to evaluate the Ayurvedic Drugs Management in Overweight Children |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF VARADI KASHAYA AND MUSTADI KWATHA IN THE MANAGEMENT OF STHAULYA W.S.R OVERWEIGHT CHILDREN:AN OPEN LABEL RANDOMIZED TRIAL.A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF VARADI KASHAYA AND M |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aarti Mal |
| Designation |
PhD Scholar |
| Affiliation |
Ayurvedic studies and research Shri Krishna AYUSH university |
| Address |
Room no 99 Pg department of Kaumarbhritya Institute of Ayurvedic studies and researchShri Krishna AYUSH university Kurukshetra Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
919582575130 |
| Fax |
|
| Email |
draarti08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Kataria |
| Designation |
Associate professor |
| Affiliation |
Ayurvedic studies and research Shri Krishna AYUSH university |
| Address |
Room no 99
Pg department of Kaumarbhritya Institute of Ayurvedic studies and research Shri Krishna AYUSH university Kurukshetra Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
9034001230 |
| Fax |
|
| Email |
dramitkataria@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit Kataria |
| Designation |
Associate professor |
| Affiliation |
Ayurvedic studies and research Shri Krishna AYUSH university |
| Address |
Room no 99
Pg department of Kaumarbhritya Institute of Ayurvedic studies and research Shri Krishna AYUSH university Kurukshetra Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
9034001230 |
| Fax |
|
| Email |
dramitkataria@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Room no 99 PG department of Kaumarbhritya Institute of Ayurvedic studies and research Shri Krishna AYUSH university Kurukshetra Haryana
Kurukshetra HARYANA 136118 India
|
|
|
Primary Sponsor
|
| Name |
Institute of Ayurvedic studies and researchShri Krishna AYUSH university |
| Address |
Institute of Ayurvedic studies and research,Shri Krishna AYUSH university, Kurukshetra, Haryana.
|
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aarti Mal |
Institute of Ayurvedic studies and research,Shri Krishna AYUSH university, Kurukshetra |
Room no 99
Pg department of Kaumarbhritya Institute of Ayurvedic studies and research Krishna AYUSH university Kurukshetra
Kurukshetra
HARYANA |
9582575130
draarti08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SHRI KRISHNA AYUSH UNIVERSITY KURUKSHETRA INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E663||Overweight. Ayurveda Condition: MEDOVRUDDHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Mustadi Kwatha, Reference: Charak Samhita Sutra Sthana Chapter-23/12-14, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 1(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Ushan Jala), Additional Information: nil | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Varadi Kashaya, Reference: SahasramYoga Kashya prakarana 63/10, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 1(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Ushan Jala), Additional Information: -nil |
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1) Children age group from 10-16 years of either sex will be selected for study.
2) Children having cardinal feature of Sthaulya (As per Subjective Parameter) will be selected.
3) Individuals having body mass index (BMI) between 85th – 95th percentile of Extended Indian Academy of Paediatrics (IAP) Body Mass Index (BMI) Chart 2015.
|
|
| ExclusionCriteria |
| Details |
1. Children age less than 10yrs & above 16 years of age were excluded from the study.
2. BMI less than 85th percentile and more than 95th percentile of Extended Indian Academy of Paediatrics (IAP) Body Mass Index (BMI) Chart 2015.
3. Waist circumference above the 90th percentile is used as a cut-off for identifying central adiposity and children who are at risk of developing metabolic syndrome.
4. Obesity due to Endocrinal cause, Monogenic disorders, Syndromes, Neurological/hypothalamic causes, Infective, brain surgery, radiotherapy, trauma; Drug induced and psychological causes.
5. Children with special health care needs (developmental and physical disabilities);
6. Children with autism spectrum disorder / attention deficit hyperactivity disorder.
7. Children with existing comorbidities related to obesity
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduce in BMI and weight of the children as per the age along with prevention of comorbidity of childhood nutritional obesity. |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in subjective parameters. |
60 days |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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
|
N/A |
|
Date of First Enrollment (India)
|
05/11/2024 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
BRIEF SUMMARY ON PURPOSE - Childhood Obesity:- Overweight and obesity in children occur due to various causes.
- The most common cause is an imbalance between calories consumed and calories expended.
- Global Challenge: Childhood obesity is one of the most pressing public health challenges of the 21st century.
- It is a global issue, particularly affecting low- and middle-income countries, especially in urban areas.
- Allopathic Medication for Weight Control: Medication for weight control should be accompanied by realistic goals.
- Initial weight loss can be achieved, but medications only work while being taken; discontinuation may lead to weight regain.
- Ayurvedic Perspective on Obesity (Sthaulya):
- Sthaulya (obesity) in Ayurveda is caused by the consumption of Kapha-increasing diet and lifestyle (Ahara and Vihara), leading to impaired Jatharagni (digestive fire) and the formation of Ama (toxins).
- This also impairs Medodhatvagni (fat metabolism).
- Ayurvedic Treatment Approach: A drug for obesity should possess properties like Deepana (appetizing), Pachana (digestive), Kapha-Vata Shamana (balancing Kapha and Vata), Srotoshodhana (clearing channels), and Medonashaka (fat-reducing).
- Study Drugs:
- Varadi Kashaya: Taken from Sahasram Yogakashya Prakarana 63/10; ingredients include Haritaki, Amalaki, Bibhitaki, Chitrak, Nisha, Asana.
- Mustadi Kwatha: Taken from Charaka Samhita Sutra Sthana Chapter 23/12-14; ingredients include Musta, Aragwadh, Patha, Amalaki, Haritaki, Vibhitaka, Devdaru, Gokhshur, Khadir, Nimba, Haridra, Daruharidra, Kutaj.
BACKGROUND OF TRIAL Childhood Obesity: A global issue due to an imbalance between calorie intake and energy expenditure, leading to health risks like diabetes and cardiovascular disease.Allopathic Treatment: Short-term weight loss but with side effects like high blood pressure, and weight often returns after discontinuing medication.Ayurvedic Perspective: Obesity (Sthaulya) results from a Kapha-increasing diet and lifestyle, leading to impaired metabolism and toxin buildup (Ama).Ayurvedic Treatment: Focuses on balancing metabolism using natural remedies that are safer and more cost-effective than allopathic treatments.Study Objective: To compare the efficacy of Varadi Kashaya and Mustadi Kwatha, two Ayurvedic formulations, in managing obesity in overweight children.Significance: Offers a natural, long-term alternative to managing childhood obesity without harmful side effects.
PRIMARY FINDING - Reduce in BMI and weight of the children as per the age along with prevention of comorbidity of childhood nutritional obesity. SECONDARY FINDING -Change in subjective parameters
|