| CTRI Number |
CTRI/2021/05/033306 [Registered on: 03/05/2021] Trial Registered Prospectively |
| Last Modified On: |
22/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of chitrak moola churna and Kapalbhati on Sthoulya (Obesity) |
|
Scientific Title of Study
|
A Clinical study to evaluate effects of Chitrak moola churna with madhu and Kapalbhati on Medodhatuagnimandya with special reference to Sthoulya |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrJyotsna Vitthalrao Yadav |
| Designation |
Ph D Scholar |
| Affiliation |
Dr D Y Patil college of ayurved and Research Centre Pimpri,Pune 411018 |
| Address |
Dr D Y Patil College of Ayurved and Research Centre Sant Tukaram Nagar Pimpri Pune
Department of Swasthavritta and Yoga OPD No 07 Dr D Y Patil college of Ayurved and Research Centre Sant tukaram nagar Pimpri
Pune
MAHARASHTRA
411018
India |
| Phone |
8805311482 |
| Fax |
|
| Email |
drjyotsnahande1988@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyotsna Vitthalrao Yadav |
| Designation |
Ph D Scholar |
| Affiliation |
Dr D Y Patil College of Ayurved and Research Centre Pimpri Pune |
| Address |
Dr D Y Patil College of Ayurved and Research Centre Pimpri Pune
Department of Swasthavritta and Yoga OPD No 07 Dr D Y Patil college of Ayurved and Research Centre Sant tukaram nagar Pimpri
Pune
MAHARASHTRA
411018
India |
| Phone |
8805311482 |
| Fax |
|
| Email |
drjyotsnahande1988@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jagmohan B Rathi |
| Designation |
Professor (Swasthavritta and Yoga) |
| Affiliation |
Dr D Y Patil College of Ayurved and Research Centre Pimpri Pune |
| Address |
Dr D Y Patil College of Ayurved and Research Centre Pimpri Pune
Department of Swasthavritta and Yoga OPD No 07 Dr D Y Patil college of Ayurved and Research Centre Sant tukaram nagar Pimpri
Pune
MAHARASHTRA
411018
India |
| Phone |
9422107455 |
| Fax |
|
| Email |
drjagmohan.rathi@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Dr D Y Patil college of Ayurveda and Research Centre Pimpri |
|
|
Primary Sponsor
|
| Name |
DrJyotsna Vitthalrao Yadav |
| Address |
Dr D Y Patil college of Ayurveda and Research Centre Sant Tukaram Nagar Pimpri Pune |
| Type of Sponsor |
Other [Self] |
|
|
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 Jyotsna Vitthalrao Yadav |
Dr D Y Patil College of Ayurved and Research Centre |
Department of swasthavritta and Yoga OPD number 07 Dr D Y Patil College of Ayurved and Research Centre Pimpri Pune 411038
Pune
MAHARASHTRA |
8805311482
drjyotsnahande1988@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E663||Overweight. Ayurveda Condition: Sthoulya(Obesity), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Chitrakmoola churna with Madhu |
500mg Chitrakmoola churna mix with 1ml of Madhu advised early in the morning at empty stomach for 45 days and Follow up After every 15 days
|
| Comparator Agent |
Kapalbhati |
25 Stroke of 20 Rounds of Kapalbhati advised early in the morning at empty stomach for 45 days and Follow up After every 15 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patient will be selected with irrespective of sex cast and religion
Patient of age group 20 to 40yrs
Body Mass index 25 to 30
Willing and able to participate in the study for 45 days
|
|
| ExclusionCriteria |
| Details |
Known case of acute complicated systemic diseases which require long term drug treatment Alcoholics and drug abusers Pregnant and lactating women.
Known case of Hormonal imbalance like hypothyroidism PCOD PV bleeding Menorrhagia Bleeding piles esophagitis etc.
Pitta prakriti and all pittaja disorders. Patients are doing any other physical exercises having cardio respiratory problems acute illness and those who had Undergone any major surgery.
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Chitrakmoola churna with madhu and Kapalbhati is effective on sthoulya.and also see the effect on BMI,BMR,Weight ,abdominal circumferences,Mid arm circumferences. |
3 follow up in 45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To see the effect of Chitrak moola churna and Kapalbhati on Lipid Profile |
3 follow up in 45 days |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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)
|
10/05/2021 |
| 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)
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
|
The aim of Study is to see the effect of chitrak moola churna with Madhu as a Anupan and Kapalbhati on Medodhatuagnimandya with special referance to Stoulya .The study will be conducted on 180 patients showing Sign and Symptoms of Stoulya and BMI in between 25 to 30 Kg/M2 .These 180 Patients are divided into 3 Groups equally .the first group will advised 500 mg Chitrakmoola Churna with Madhu at early in the morning empty stomach for 45 days and follow up every 15 days. The second group will advised Kapalabhati. 25 stroke of 20 rounds of Kapalbhati at early in the morning empty stomach for 45 days and follow up every 15 days. The third group will advised Chitrakmoola churna with Madhu and Kapalbhati at early in the morning empty stomach for 45 days and follow up every 15 days. Conclusion will be drawn on the basis of proper statistical method. |