| CTRI Number |
CTRI/2018/10/016123 [Registered on: 23/10/2018] Trial Registered Prospectively |
| Last Modified On: |
26/11/2019 |
| 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 TRYUSHANADI GUGGULU AND NAVAKA GUGGULU IN THE PATIENTS HAVING SIGN AND SYMPTOMS OF MEDOROGA (ADIPOSOPATHY) |
|
Scientific Title of Study
|
“PRAKRITI- A RISK FACTOR FOR MEDO ROGA (ADIPOSOPATHY): WHO STEPS BASED NIDANATMAKA STUDY AND RANDOMIZED UPASHAYATMAKA (CLINICAL) TRIAL OF TRYUSHANADI GUGGULU AND NAVAKA GUGGULU†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR BALENDRA SINGH |
| Designation |
M.D.SCHOLAR |
| Affiliation |
NATIONAL INSTITUTE OF AYURVEDA JAIPUR |
| Address |
P.G.DEPARTMENT OF ROGA EVAM VRIKRITI VIGYAN,NATIONAL INSTITUTE OF AYURVEDA, MADHAV VILAS PALACE, JORAWAR SINGH GATE, AMER ROAD JAIPUR
Jaipur
RAJASTHAN
302002
India |
| Phone |
7587184418 |
| Fax |
|
| Email |
balobamsias@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR PAWAN KUMAR GODATWAR |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
NATIONAL INSTITUTE OF AYURVEDA,JAIPUR |
| Address |
P.G.DEPARTMENT OF ROGA EVAM VRIKRITI VIGYAN,NATIONAL INSTITUTE OF AYURVEDA, MADHAV VILAS PALACE, JORAWAR SINGH GATE, AMER ROAD JAIPUR
Jaipur
RAJASTHAN
302002
India |
| Phone |
9314502834 |
| Fax |
|
| Email |
gpawankumar@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR PAWAN KUMAR GODATWAR |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
NATIONAL INSTITUTE OF AYURVEDA,JAIPUR |
| Address |
P.G.DEPARTMENT OF ROGA EVAM VRIKRITI VIGYAN,NATIONAL INSTITUTE OF AYURVEDA, MADHAV VILAS PALACE, JORAWAR SINGH GATE, AMER ROAD, JAIPUR
Jaipur
RAJASTHAN
302002
India |
| Phone |
9314502834 |
| Fax |
|
| Email |
gpawankumar@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| PHARMACY OF NATIONAL INSTITUTE OF AYURVEDA, JAIPUR |
|
|
Primary Sponsor
|
| Name |
NATIONAL INSTITUTE OF AYURVEDA JAIPUR |
| Address |
NATIONAL INSTITUTE OF AYURVEDA, MADHAV VILAS PALACE,JORAWAR SINGH GATE, AMER ROAD JAIPUR, RAJASTHAN 302002, INDIA |
| 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 BALENDRA SINGH |
NATIONAL INSTITUTE OF AYURVEDA JAIPUR |
PG department of Roga Evam Vikriti Vigyan, OPD and IPD of hospital, Madhav Vilas Palace, Jorawar Singh Gate, Amer Road Jaipur, Rajasthan 302002
Jaipur
RAJASTHAN |
7587184418
balobamsias@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE NATIONAL INSTITUTE OF AYURVEDA,JAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E669||Obesity, unspecified, (2) ICD-10 Condition: E668||Other obesity, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NAVAKA GUGGULU |
CONTENTS-Shunthi(Zingiber officinale),Maricha(Piper nigrum),Pippali(Piper longum),Chitraka(Plumbago zeylanica),Haritaki(Terminalia chebula),Vibhitaki(Terminalia bellarica),Amalaki(Emblia officinalis),Musta(Cyperus rotundus),Vidanga(Embelia ribs),Guggulu(Commiphora mukul) |
| Intervention |
TRYUSHANADI GUGGULU |
CONTENTS-Shunthi(Zingiber officinale),Maricha(Piper nigrum),Pippali(Piper longum),Chitraka(Plumbago zeylanica),Musta(Cyperus rotundus),Vidanga(Embelia ribs),Vacha(Acorus calamus),
Guggulu(Commiphora mukul),
Ghrita
dose-2 Vati (500 mg each) twice a day after meals
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1-SUBJECTS OF AGE 18 - 60 YEARS.
2-SUBJECTS OF EITHER SEX.
3-SUBJECTS FOUND TO BE SUFFERING WITH MEDOROGA IN THE NIDANATMAKA STUDY ON THE BASIS OF PARAMETERS SUCH AS ADIPOSOPATHY & DYSLIPIDEMIA AS WELL AS THE AYURVEDIC PARAMETERS AND THEREAFTER CONSENTING TO PARTICIPATE IN THE DRUG TRIAL AND NOT FALLING IN THE EXCLUSION CRITERIA WILL BE INCLUDED
|
|
| ExclusionCriteria |
| Details |
1-Patients having diabetes mellitus, malignant hypertension and other malignant disorders.
2-Patient having Hypersensitivity, anorexia nervosa, history of Coronary artery disease, Congestive heart failure (CHF), arrhythmias, stroke, cardiac disorders, and those receiving Mono amino oxidase inhibitors (MAOIs ) etc.
3-Pregnant and lactating mothers.
4-Patients having any hormonal disturbances like hypothyroidism.
5-Patients not complying with the directions of the physician.
6-BMI > 40 kg/m2
7-Patient with major complications and in requirement of emergency treatment. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| patients of both sexes between age group 18 to 60 years of medoroga will be selected for relieving sign and symptoms |
4 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Asses the comparative efficacy between Tryushanadi Guggulu and Navaka Guggulu in case of medoroga. |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
05/11/2018 |
| Date of Study Completion (India) |
18/03/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not published yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This is an Open label Randomised single centre trial comparing efficacy of ayurvedic drugs Tryushanadi Guggulu and Navaka Guggulu in the management of Medoroga (adiposopathy). Patient of both sexes between age 18 to 60 years of medoroga will be selected for relieving sign and symptoms. 60 clinically diagnosed and confirmed patients will be randomly divided into two groups for administration of trial drugs. In group I, 30 patients will be administered trial drug tryushanadi guggulu in the dose of 1 gm BD orally for 4 weeks. In group II, 30 patients will be administered trial drug navaka guggulu in the dose of 1 gm BD orally for 4 weeks.All the patients registered for the clinical trial will be asked for any changes in their clinical manifestations and growing feeling of well being. Conclusion- to compare the efficacy of both the drugs. |