| CTRI Number |
CTRI/2021/01/030681 [Registered on: 22/01/2021] Trial Registered Prospectively |
| Last Modified On: |
01/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study held to see the effect of triphaladi enema in management of obesity. |
|
Scientific Title of Study
|
Clinical study on the effect of Triphaladi Kaal basti in management of sthoulyaroga (obesity). |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR DEEPA CHATURVEDI |
| Designation |
MD SCHOLAR PANCHAKARMA |
| Affiliation |
DR D Y PATIL DEEMED TO BE UNIVERSITY |
| Address |
OPD NO 9 PANCHAKARMA DEPARTMENT DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI
PUNE 18 SANT TUKARAM NAGAR
Pune
MAHARASHTRA
411018
India |
| Phone |
8856975420 |
| Fax |
|
| Email |
deepachaturvedi1314@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MAMATA NAKADE |
| Designation |
PROFESSOR |
| Affiliation |
DR D Y PATIL DEEMED TO BE UNIVERSITY |
| Address |
OPD NO 9 PANCHAKARMA DEPARTMENT DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI
PUNE 18 SANT TUKARAM NAGAR
Pune
MAHARASHTRA
411018
India |
| Phone |
9850241887 |
| Fax |
|
| Email |
mamtaraut1966@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR DEEPA CHATURVEDI |
| Designation |
MD SCHOLAR PANCHAKARMA |
| Affiliation |
DR D Y PATIL DEEMED TO BE UNIVERSITY |
| Address |
OPD NO 9 PANCHAKARMA DEPARTMENT DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI
PUNE 18 SANT TUKARAM NAGAR
Pune
MAHARASHTRA
411018
India |
| Phone |
8856975420 |
| Fax |
|
| Email |
deepachaturvedi1314@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE DEEMED TO BE UNIVERSITY PIMPRI PUNE |
|
|
Primary Sponsor
|
| Name |
DR DEEPA CHATURVEDI |
| Address |
OPD NO 9 PANCHAKARMA DEPARTMENT DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI PUNE 18 SANT TUKARAM NAGAR |
| 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 DEEPA CHATURVEDI |
DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE DEEMED TO BE UNIVERSITY PIMPRI PUNE |
OPD NO 9 PANCHAKARMA DEPARTMENT DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI PUNE 18 SANT TUKARAM NAGAR
Pune
MAHARASHTRA |
8856975420
deepachaturvedi1314@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Recognition Commitee Meeting |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E669||Obesity, unspecified. Ayurveda Condition: Sthoulyaroga, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Clinical study on the effect of Triphaladi Kaal basti in management of sthoulyaroga (obesity). |
62 patients will be selected and treated in Kaal basti manner with Triphaladya Tail and Triphaladi Kwath for 16 days.
Dose:
Triphaladya Tail - 120ml.
Triphaladi Kwath - 960ml.
Timing:
Triphaladya Tail - After meal, once in a day.
Triphaladi Kwath - Empty stomach(in morning), once in a day.
Follow up: After 15th day |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients having clinical symptoms - Anga-chalatva, Kshudra shwasa, Swedadhikya, Daurgandhya, Snigdhangata, chala-sphig, udar, stan of sthoulya roga included in this study.
2)Patient associated with diabetes mellitus and Polycystic Ovarian Syndrome.
3)Age: 20-60 years. |
|
| ExclusionCriteria |
| Details |
1)Patient associated with any other systematic disorders like cardiac disorders- Myocardial infarction, Hypothyroidism, Hypertension.
2)Pregnancy and Lactation. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.)Sthoulya roga is medadhatu dusti janya vikar due to medadhaatvaagni dusti. Sthoulya means excessive deposition of unwanted medadhatu.
2.)To evaluate the effect of Triphaladi Kaal basti in management of sthoulyaroga (obesity) |
16 Days study with one follow up on 15th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Triphaladi Kaal basti is the effective management of sthoulyaroga (obesity). |
16 Days with one follow up on 15th day. |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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 2 |
|
Date of First Enrollment (India)
|
25/01/2021 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim of the study will be to give Ayurvedic Treatment to diseased patient to improve his/her condition and we can give his/her cheap, safe, side effect free management. The Trial will be conducted on 62 patients for 16 days and dose of drug done one time in a day and follow up on 15th Day . |