| CTRI Number |
CTRI/2018/06/014348 [Registered on: 01/06/2018] Trial Registered Prospectively |
| Last Modified On: |
31/05/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Clinical Study on the Effect of Virechana in Sthaulya Vis-Vas obesity. |
|
Scientific Title of Study
|
Randomized Clinical Comparative Study on the Effect of Virechana Followed with and without Dashanga Guggul in Sthaulya |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Seema Dhakane |
| Designation |
MD Kaychikitsa(PG Scholar) |
| Affiliation |
Govt. Ayurved college Nagpur |
| Address |
Departmnt of Kayachikitsa
Government Ayueved College
Sakkardara Chowk
Nagpur
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9702065999 |
| Fax |
07122749198 |
| Email |
seemagarje2012@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrKabra R Prakash |
| Designation |
Professor |
| Affiliation |
Govt. Ayurved College Nagpur |
| Address |
Departmnt of Kayachikitsa
Government Ayueved College
Sakkardara Chowk
Nagpur
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9225226567 |
| Fax |
07122749198 |
| Email |
kabraprakash2711@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Seema Dhakane |
| Designation |
MD Kaychikitsa(PG Scholar) |
| Affiliation |
Govt.Ayurved college Nagpur |
| Address |
Departmnt of Kayachikitsa
Government Ayueved College
Sakkardara Chowk
Nagpur
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9702065999 |
| Fax |
07122749198 |
| Email |
seemagarje2012@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self(Seema Dhakane) Department of Kaychikitsa Government Ayurved college Nagpur. |
|
|
Primary Sponsor
|
| Name |
Government Ayurved College Nagpur |
| Address |
Sakkardara Chowk Nagpur
|
| Type of Sponsor |
Other [Government Ayurved College Nagpur] |
|
|
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 |
| Seema Prabhakar Dhakane |
Government Ayurved Hospital Nagpur |
Departmnt of Kayachikitsa
Government Ayueved College
Sakkardara Chowk
Nagpur
Nagpur
MAHARASHTRA |
9702065999
07122749198
seemagarje2012@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee Government Ayurved College Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
With controlled Systemic disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Rukshana Pachana
Kvath:40ml/BD Triphala, Musta,
Vidanga, Guduchi Choorna
Ichabhedi Ras: 250mg Parada
III Shunthi V Marich Gandhaka
IV Tankana VI Shuddha Jayapal
beej Dashang guggul
500mg/BD Vyosha ,Musta
Chitraka Vidanga Triphala
Guggul
|
First Assessment: Rukshana
Pachana Kvath: On next day,
will be called as first day,
Rukshana Pachana Kvath will
be given to the obese patients
for 3 to 5 days before Snehpana
(A.H.S 16 /37-38). [21] (A.H.S
14/12,13,14). [22] Snehpana:
After Rukshana Pachana Kvath
Snehpana will be given by
Triphaladi Tail for three to seven
days (Ck. S 36/31,32,33) [23].
Dose of Triphaladi Tail for
Snehpana will be changed as
per requirement. Generally, it
will be started in the dose of 25
ml and will be increased. .
(A.H.S.16/30)[28] Second
Assessment after Snehpana:
Second assessment will be
done after completion of
Snehpana on next day of
achieving Samyaka symptoms
of Snehpana. Rest Day: 5) Rest
will be advised for three days
Virechana: Virechana will be
administering Ichchabhedi Rasa
250mg by following the rules
given for Virechana. Patients
will be admitted in the hospital
for close vigilance. Third
Assessment after Virechana:
Assessment will be done on the
next day after Samsarjana
Krama i.e. after completion of
Virechana Karma. This
assessment will be third
assessment.Shamana Chikitsa:
Dashanga Guggul will be given
in the dose of 500mg, two times
per day for a period of 30 days,
with Anupana of lukewarm
water to the patients of Group
A. Fourth Assessment after
Shamana (Final Assessment):
For Group A: Fourth and Final
assessment will be done after
completion of Shamana Chikitsa
i.e. after completion of
administration of Dashanga
Guggul for a period of one
month only in Group A. This
assessment for patients from
Group A in which Virechana and
Dashanga Guggul is given, will
be final assessment and will be
termed as After Treatment. For
Group B: Patients from Group B
will be advised to follow strict
diet During this period, patients
will be asked to visit OPD per
week.
|
| Intervention |
virechan without Dashang
Guggul in Group B Rukshana
Pachana Kvath:40ml/BD
Triphala, Musta, Vidanga,
Guduchi Choorna Ichabhedi
Ras: 250mg Parada III Shunthi
V Marich Gandhaka IV Tankana
VI Shuddha Jayapal beej
|
These patients will be classified
in to two groups of
management. These groups will
be termed as Group A and
Group B. These patients will be
categorized in to Group A and
Group B by lottery method with
patients in each group.
Virechana followed by
Dashanga Guggul will be
administered to the patients of
Group A. Only Virechana will be
given to the patients of Group B.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.patients of clinical features of Sthaulya.
2.body mass index from 25kg/m2 to 35kg/m2.
3.patients of Sthaulya with controled HTN and DM.
4.Patients with total cholesterol less than 300mg/dl
|
|
| ExclusionCriteria |
| Details |
1.Patients of obesity due to hypothyroidism Cushing’s syndrome,
Steroid induced obesity or Obesity due to any other systemic
disorders.
2.Drug induced obesity for example Hormonal replacement therapy,
calcium channel blockers, consumption of anabolic steroids etc.
3.Pregnant females & lactating mothers.
4.Patients who are currently participating in other clinical trials (since
last six months).
5.Obesity because of heredity will be excluded.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)To evaluate the effect of Snehpana on body
mass index, waist hip ratio and lipid profile.
2)To evaluate the effect of Snehpana and
Virechana separately on body mass index, waist
hip ratio and lipid profile.
3)To evaluate the effect of Snehpana followed by
Virechana and Dashang Guggul as Shamana
drug on body mass index, waist hip ratio and
lipid profile.
|
1)On zero day i.e. B.T.value
2)Rukshana Pachana Kvath will be given for 5
days.
3)From 6th day Snehapana will be administered
for seven days and assessment will be done on
13th day.
4)Virechana will be given on 16 th day and
assessment will be done on 21 rst day.
5) Final assessment will be done on 51 rst day
i.e. Dashanga Guggulu will be given for 30 days.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
II} Secondary objectives:
1) To review and study literature of Sthaulya.
2) To review and study literature of Obesity.
|
One and half year
|
|
|
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 2 |
|
Date of First Enrollment (India)
|
06/06/2018 |
| 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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Obesity is a life style oriented disorder caused by excessive eating and lack of adequate exercise is discouraged by the society because of high incidence of Diabetes mellitus, hypertension, angina pectoris, and myocardial infarction etc. In Ayurved it can be correlated with Sthaulya explained by different Acharya’s in their respective texts. Charaka included it in the eight varieties of impediments which is treated by Shodhana followed by Shamana.This is a project entitled “Open Randomized Study on Effect of Triphaladi Tailapana and Virechana Followed by Administration of Dashanga Guggul in Sthaulya†All the parameters of assessment will be based on the signs and symptoms of Sthaulya mentioned in text. Patients fulfilling the criteria will be selected and allocated in one group followed by a filling of consent form in language best understood by them. All the parameters will be assessed before and after treatment based on the specially prepared proforma. Appropriate test will be applied to the data outcome and discussion and conclusion will be made accordingly.  
|