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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  
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 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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E663||Overweight. Ayurveda Condition: ATISTHAULYAM (KEVALA-KAPHA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-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
2Intervention ArmDrugClassical(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. 
 
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