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CTRI Number  CTRI/2023/03/050486 [Registered on: 09/03/2023] Trial Registered Prospectively
Last Modified On: 06/03/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A pilot study to evaluate the role of Yoga capsule as add on in reducing serum glucose levels in diabetes.  
Scientific Title of Study   A pilot study to evaluate the role of Yoga capsule as add on in reducing serum glucose levels in diabetes. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sulochana Bhat 
Designation  Assistant Director Incharge 
Affiliation  Central Ayurveda Research Institute 
Address  No.12 Valley School Road Uttarahalli Manavarthekaval Uttarahalli hobli Thalaghattapura post Kanakapura Road Bengaluru

Bangalore
KARNATAKA
560109
India 
Phone  9968053646  
Fax    
Email  dr.sulochana@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Monica KP 
Designation  Senior Research Fellow  
Affiliation  Central Ayurveda Research Institute 
Address  No.12 Valley School Road Uttarahalli Manavarthekaval Uttarahalli hobli Thalaghattapura post Kanakapura Road Bengaluru

Bangalore
KARNATAKA
560109
India 
Phone  7411338556  
Fax    
Email  kpmonicajune@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Chandini Chandrasekharan NP 
Designation  Consultant 
Affiliation  Central Ayurveda Research Institute 
Address  No.12 Valley School Road Uttarahalli Manavarthekaval Uttarahalli hobli Thalaghattapura post Kanakapura Road Bengaluru

Bangalore
KARNATAKA
560109
India 
Phone  9901537911  
Fax    
Email  chandni.nambiar@gmail.com  
 
Source of Monetary or Material Support  
Centre of Excellence scheme of Ministry of Ayush Government of India awarded to CARI Bengaluru  
 
Primary Sponsor  
Name  Ministry of Ayush, Government of India 
Address  Ayush Bhawan B Block GPO Complex INA New Delhi 110023 
Type of Sponsor  Government funding agency 
 
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 Monica KP  Central Ayurveda Research Institute  Central Ayurveda Research Institute Manavarthekaval, Uttarahalli, Hobli, Bengaluru – 560109
Bangalore
KARNATAKA 		 7411338556

kpmonicajune@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee CARI Bengaluru  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E08-E13||Diabetes mellitus. Ayurveda Condition: PRAMEHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Treatment as it isThe subjects will continue with the same medication for the trial period without any dose/medicine modification
2Intervention ArmLifestyle--Dinacarya: Introducing Yoga capsule, Ritucarya: Introducing Yoga capsule, Acara Rasayana:not applicable, Other:nil, Pathya/Apathya:no, Pathya:, Apathya:
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Subjects of all gender, 18-60 years
2. Freshly diagnosed or known diabetic subjects with HbA1c of 5.7-9 % (both values included).
3. Subjects who agree to participate in the study and submit a written informed consent form.
4. Individuals physically fit to practice yoga protocol.
 
 
ExclusionCriteria 
Details  1. Subject diagnosed with type 1 Diabetes.
2. Subjects with Haemoglobin percentage < 8 g/dl.
3. Subjects with uncontrolled hypertension (with or without medication systolic >140 and/or diastolic >90 mmHg after 10 minutes of rest)
4. Subjects with established diagnosis of CAD or any other clinically significant cardiovascular disease.
5. Uncontrolled acute Pulmonary Dysfunction requiring inhalation or systemic steroids.
6. Pregnant / Lactating women.
7. Female subject of child bearing potential who do not agree to remain abstinent or use medically acceptable methods of contraception during the study therapy.
8. Subject who has undergone major surgical interventions in the past 2 years.
9. Subject on systemic or oral steroids, oral contraceptive pills or oestrogens replacement therapy.
10. Subjects with a current diagnosis of malignancy or in the last five years.
11. Subjects suffering from major systemic illness necessitating long-term drug treatment (defined as more than 3 months).
12. Subjects who are not able to practice the yoga protocol.
13. Any other condition that the Investigator thinks may jeopardize the safety of the subject.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Dates of Birth or day of the Week 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Change in serum glucose levels from baseline to 84 days.  1. Change in serum glucose levels from baseline to 84 days. 
 
Secondary Outcome  
Outcome  TimePoints 
1.Change in BMI and waist circumference at baseline & 84 days.
2.Change in Symptoms - Diabetes Symptoms Questionnaire (DSQ): At baseline, 28, 56 and 84days.

 		 1.Change in HbA1C, FBS, PPBS, Haematology at Baseline, 84th day
2.Change in BMI, Waist circumference at Baseline , 84th day
3.Change in Diabetes Symptoms Questionnaire (DSQ)at Baseline, 28, 56, 84th day
4.Any SAE/ADR at 28, 56, 84th day
5. Treatment Compliance at 28, 56, 84th day
 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   15/03/2023 
Date of Study Completion (India) 16/02/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 16/02/2024 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   A glimpse at yoga books illustrates the daily practice of yoga can help in preventing diabetes, maintaining blood sugar levels in diabetics, and sidestepping the complications of diabetes. The practice of yoga requires a great amount of determination and time, which is difficult for a beginner. With a view of introducing diabetic patients to yoga, this abridged version of “Yoga Capsule” which comprehends asanas and pranayama’s that are effective on diabetes has been devised in consultation with renounced experts. However, the study hopes at initiation of Yoga in patients of diabetes as a valid fragment of treatment protocol, to monitor the effect on serum glucose levels , BMI, waist circumference, changes in DS, this also validates the proposed Yoga Capsule in management of Diabetes as a potential life style modification.  
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