| CTRI Number |
CTRI/2019/05/018944 [Registered on: 03/05/2019] Trial Registered Prospectively |
| Last Modified On: |
02/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Treatment of obesity |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the efficacy of Sthaulyapakarshaniya kwatha and Lekhana basti in Sthaulya (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 Dinesh Kumar Goyal |
| Designation |
Professor |
| Affiliation |
Gurukul Campus, Uttarakhand Ayurveda University, Haridwar |
| Address |
Department of Kayachikitsa, Gurukul Campus, Uttarakhand Ayurveda University, Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9411731180 |
| Fax |
|
| Email |
dineshdr157@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dinesh Kumar Goyal |
| Designation |
Professor |
| Affiliation |
Gurukul Campus, Uttarakhand Ayurveda University, Haridwar |
| Address |
Department of Kayachikitsa, Gurukul Campus, Uttarakhand Ayurveda University, Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9411731180 |
| Fax |
|
| Email |
dineshdr157@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dinesh Kumar Goyal |
| Designation |
Professor |
| Affiliation |
Gurukul Campus, Uttarakhand Ayurveda University, Haridwar |
| Address |
Department of Kayachikitsa, Gurukul Campus, Uttarakhand Ayurveda University, Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9411731180 |
| Fax |
|
| Email |
dineshdr157@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gurukul Campus, Uttarakhand Ayurveda University, Haridwar
Pin code 249404 |
|
|
Primary Sponsor
|
| Name |
Uttarakhand Ayurveda University Harrawala Dehradoon |
| Address |
Uttarakhand Ayurveda University, Harrawala, Dehradoon |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sujata |
Gurukul Campus, Uttarakhand Ayurveda University, Haridwar |
O.P.D. No. 5, P.G. Department of Kayachikitsa
Hardwar
UTTARANCHAL |
8114465839
sujata.choudhary.7330@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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Basti
|
Patients will be treated with 6 Lekhana Basti (LB)in a dose of 450 ml. through anal route and 10 Anuvasana Basti (AB) with triphala tail in a dose of 50 ml. through anal route only.Two episodes of Kala basti will be planned with the interval of 14 days in between. |
| Comparator Agent |
Basti with oral medication |
Patient will be treated with both i.e. Sthaulyapkarshaniya kwath and Lekhana basti (SK+LK) for 2 months similar to the other two groups. |
| Intervention |
Oral medication |
Patients will be treated by Sthaulyapakarshaniya kwath (SK)orally in a dose of 40 ml twice a day for two months. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Well diagnosed patients of sthaulya. (Diagnosis will be made on the basis of assessment criteria as mentioned in classical texts.)
Patients having BMI in range of 25 – 35 kg/m2.
Patients with hyperlipidemia and/or type 2 DM |
|
| ExclusionCriteria |
| Details |
Patients having BMI more than 35 kg/m2.
Patients of age below 20 or more than 50 years.
Patients having major systemic disorders or other illness which interfere with the present study.
Patients of sthaulya with its severe complications like cerebral vascular diseases, ischemic heart diseases etc.
Patients with depression or having any other mental or psychiatric disorder.
Cases with alcohol dependence/ misuse and drug abuse.
Obesity associated with endocrinopathies.
Pregnancy.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Complete remission - 100% relief
Marked improvement - 66 to 99% relief
Moderate improvement - 33 to 66% relief
Mild improvement - 1 to 33% relief
Unchanged - 0% |
2 months of assessment period during treatment with 1 month of follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Exacerbation in sign and symptoms |
2 months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/05/2019 |
| Date of Study Completion (India) |
01/01/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
01/01/2020 |
|
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
Modification(s)
|
Trial is completed |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
There
are various treatment modalities for sthaulya.
Both the shodhana therapies and shamana therapies are mentioned for sthaulya. Since, the pathogenesis of sthaulya is due to the vitiation of ‘agni’, ‘vata’ and ‘meda’, the
treatment also should be accordingly. It should be vatashamaka, agnisamyakara
and medoshoshaka. The treatment is
opposite in nature and is very difficult to treat. So,
today there is a need to find the drug which is cost effective, easily
available and easy to follow. One such preparation might be Sthaulyapakarshaniya
kwatha which has few ingredients that are easily available. It has been
mentioned in Charak Samhita. It has the properties like Aampachana, Medoshoshana
and Vata-kaphahar. Lekhana
basti which has been praised for its scraping action has also been
considered for this research. Their effect at individual as well as combined level
can be observed in hope to put an end to obesity. On
the light of above, present study has been selected. |