CTRI Number |
CTRI/2023/08/056612 [Registered on: 17/08/2023] Trial Registered Prospectively |
Last Modified On: |
13/08/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Yoga & Naturopathy |
Study Design |
Non-randomized, Active Controlled Trial |
Public Title of Study
|
Combined effect of Yavamalaka choorna and Suryanamaskara to reduce the Body Mass Index of Overweight adults aged 25-45 years |
Scientific Title of Study
|
Combined effect of Yavamalaka Choorna and Suryanamaskara in Overweight adults |
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 Shibina E S |
Designation |
PG Scholar,Dept of Swasthavritta |
Affiliation |
Govt Ayurveda Medical College and Hospital |
Address |
Government Ayurveda Medical College and Hospital,Pulimoodu junction,Thiruvanathapuram,Kerala
Thiruvananthapuram KERALA 695001 India |
Phone |
8281596220 |
Fax |
|
Email |
shibinaes@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Shibina E S |
Designation |
PG Scholar,Dept of Swasthavritta |
Affiliation |
Govt Ayurveda Medical College and Hospital |
Address |
Government Ayurveda Medical College and Hospital,Pulimoodu junction,Thiruvanathapuram,Kerala
Thiruvananthapuram KERALA 695001 India |
Phone |
8281596220 |
Fax |
|
Email |
shibinaes@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Jayan D |
Designation |
Professor and HOD,Dept of Swasthavritta |
Affiliation |
Govt Ayurveda College and Hospital |
Address |
Government Ayurveda College and Hospital,Dhanwantari nagar,Tripunithura
Ernakulam KERALA 682301 India |
Phone |
9447104383 |
Fax |
|
Email |
dr.jayan.d@gmail.com |
|
Source of Monetary or Material Support
|
Govt Ayurveda Medical College and Hospital,Thiruvanathapuram |
|
Primary Sponsor
|
Name |
Shibina E S |
Address |
PG Scholar,Govt Ayurveda Medical College and Hospital,Thiruvananthapuram |
Type of Sponsor |
Other [Govt Ayurveda Medical College,Thiruvanathapuram] |
|
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 Shibina E S |
Govt Ayurveda Panchakarma Hospital,Poojappura,Thiruvananthapuram |
Dept of Swasthavritta,OP No-2 Thiruvananthapuram KERALA |
8281596220
shibinaes@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
INSTITUTIONAL ETHICAL COMMITTEE(IEC),Govt ayurveda college,Thiruvanathapuram,Kerala,India |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:E663||Overweight. Ayurveda Condition: ATISTHAULYAM (KEVALA-KAPHA), |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Comparator Arm | Procedure | - | Suryanamaskara | (Procedure Reference: Pathanjali yogasuthra, Procedure details: Suryanamaskara daily one hour morning for 45 days) (1) Medicine Name: Yavamalaka choorna, Reference: Charaka samhitha sutrasthana, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Duration: 45 Days | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Yavamalaka choorna, Reference: Charaka samhitha sutrasthana, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -warm water), Additional Information: - |
|
|
Inclusion Criteria
|
Age From |
25.00 Year(s) |
Age To |
45.00 Year(s) |
Gender |
Both |
Details |
Subjects within Body Mass Index between 25 and 29.9KG/M2
Waist Hip Ratio greater than 0.95 in Males and 0.80 in Females |
|
ExclusionCriteria |
Details |
Known cases of Thyroid disorders,PCOD,or other Chronic Systemic disorders.
Pregnant ladies and Lactating women.
Subjects under Steroid therapy.
Subjects who have done any surgeries within last 6 months.
Subjects who are unable to do Suryanamskara properly. |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Body Mass Index |
0th day,31st day,46th day
|
|
Secondary Outcome
|
Outcome |
TimePoints |
Waist Hip Ratio |
0th day,31st day,46th day |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
25/08/2023 |
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="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
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
|
WHO defines overweight is a Body Mass Index(BMI) between 25 and 30.In Ayurveda, Overweight can be correlated to Sthoulya. Management principle of overweight aims at reducing the energy intake and increasing energy expenditure and thereby maintaining the balance between both. Yava and Amalaki, which are among the food articles for daily consumption , are mentioned to have medohara action. Since dietary management and physical activity have a major role in overweight, yoga is the most suitable option for this. Suryanamaskara is the powerful yoga technique which contains 12 rhythmic yogasanas. A Quasi experimental study will be conducted in 60 participants of all sexes, satisfying inclusion and exclusion criteria. Out of 60 participants,30 each will be consecutively selected and allocated to study group and control group in odd and even manner. The study group wlll be given 6g Yavamalaka choorna twice daily with warm water half an hour before food along with regular practice of Suryanamaskara at morning while the control group was given Suryanamaskara alone. Both the groups will be advised to follow same diet chart. The study period is 45 days. The Body Mass Index and Waist Hip ratio will be assessed on 0th day,31st day and 46th day and follow up will be done for 15 days. |