| CTRI Number |
CTRI/2019/02/017517 [Registered on: 07/02/2019] Trial Registered Prospectively |
| Last Modified On: |
06/02/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effect of Trayushnadi guggulu and virechan karma in sthaulya. |
|
Scientific Title of Study
|
Management of Sthaulya (Obesity) with Trayushnadi Guggulu along with and without prior Virechana- An open labelled randomized comparative clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vibhutikumari M Chaudhari |
| Designation |
Pg Scholar |
| Affiliation |
Govt Akhandanand Ayurved college Bhadra Ahmedabad |
| Address |
Room no 11 Panchkarma Department Govt Akhandanand Ayurved college Bhadra Ahmedabad
Ahmadabad
GUJARAT
380001
India |
| Phone |
9737323971 |
| Fax |
|
| Email |
vib1393@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sweety Ruparel |
| Designation |
Professor |
| Affiliation |
Govt Akhandanand Ayurved college Bhadra Ahmedabad |
| Address |
Room no 11 Panchkarma Department Govt Akhandanand Ayurved college Bhadra Ahmedabad
Ahmadabad
GUJARAT
380001
India |
| Phone |
9429202048 |
| Fax |
|
| Email |
sweetyruparel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vibhutikumari M Chaudhari |
| Designation |
Pg scholar |
| Affiliation |
Govt Akhandanand Ayurved college Bhadra Ahmedabad |
| Address |
Room no 11 Panchkarma Department Govt Akhandanand Ayurved college Bhadra Ahmedabad
Ahmadabad
GUJARAT
380001
India |
| Phone |
9737323971 |
| Fax |
|
| Email |
vib1393@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no 11 Panchkarma Department Govt Akhandanand Ayurved college Bhadra Ahmedabad |
|
|
Primary Sponsor
|
| Name |
Govt Akhandanand Ayurved college |
| Address |
Govt Akhandanand Ayurved college Bhadra Ahmedabad |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Vibhutikumari M Chaudhari |
Govt Akhandanand Ayurved College |
Room no 11 Panchkarma department Govt Akhandanad Ayurved College Ahmedabad
Ahmadabad
GUJARAT |
9737323971
vib1393@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: E669||Obesity, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Trayushnadi guggulu |
Trayushnadi guggulu will be prepared as described in Sharangdhar Samhita (GugguluKalpana)
Dose 12 gm in a day in tablet form in three divided doses (each tablet 500 mg)
With Ushnodaka for 8 weeks |
| Comparator Agent |
VirechanaPoorvakShamana(Trayushandi guggulu) |
Shodhana Virechan Karma is
divided into 3 parts PurvaKarma
Deepana andPachana Drug
TrikatuChurna Dose 4 to 6 gm
per day 2 to 3 gm twise a dayas
per Aatur-Agni Duration3 to 5
days till lakshana of Agnidipti
appeared Aabhyantar Snehpan
Sneha dravya Trayushnadi Ghrit
Dose 20 to 40 ml
starting dose in Vardhmana
Krama As perAatur-Koshtha
and Agni Time Naishejirne
Duration 3 to 7 days depending
upon the Samyak-Snigdha
Lakshana Anupan Ushnodak
Diet Light diet Drav Ushana
Annaabhishyandi Pramanatha
Natisnighdha Asnkrina
Abhyanga and Swedana Time
After completion of Abhyantara
Snehapana 1st day and 2nd day during Vishrama Kala 3rd day – Prior to Virechana Karma
Diet drav ushna
Pittavrudhdhikar will be given
in the dinner at previous night of Virechan Karma
Pradhan karma Virechana Karma with Trivrut Varadi Yoga dose 40-60 gm At Shleshma Kale Gate with Ushnodak after virechana karma Samsarjana Karma will be advised according to shudhdhi 3 5 or 7 days for shamana treatment trayushnadi guggulu will be given for 8 week |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
classical signs & symptoms of Sthaulya (Javoparadh, Kriccha Vyavayta, Daurbalya, Daurgandhya, Swedabadh, Atikshudha, Atipipasa)
BMI (Body Mass Index) ≥ 25 and ≤ 35
In Shodhana group Virechy |
|
| ExclusionCriteria |
| Details |
Patients suffering from Pulmonary diseases, Cardiac diseases, Hypothyroidism, Hypertension, PCOD, HIV Patients having B.M.I. more than 35
In Shodhana group Avirechya
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Result will be assessed on the basis of sign and
symptoms of Sthaulya and By observing BMI Body Circumference
|
8 Weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Result will be assessed on the basis of changes in cholesterol triglycerides LDL HDL and VLDL values from baseline |
8 Weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
18/02/2019 |
| 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="0"
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
|
To study the effect of Trayushnadi guggulu with Virechana karma and without Virechana karma in the management of Sthaulya obesity this study is randomized open label parallel group trial |