| CTRI Number |
CTRI/2011/12/002281 [Registered on: 23/12/2011] Trial Registered Retrospectively |
| Last Modified On: |
07/12/2011 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Management of lipid disorder with ayurveda |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY OF ASANADI GHANAVATI AND GOMUTRA-HARITAKI VATI IN KAPHA MEDO MARGAVARANA W.S.R TO DYSLIPIDEMIA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shivam Joshi |
| Designation |
MD Scholar kaya chikitsa |
| Affiliation |
Institute for post graduation training and research in ayurveda |
| Address |
OPD no 16 department of kayachikitsa IPGT&RA Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
09427230432 |
| Fax |
|
| Email |
ayuholistichealth@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof H M Chandola |
| Designation |
HOD Kaya chikitsa |
| Affiliation |
Institute for post graduation training and research in ayurveda |
| Address |
Department of kayachikitsa IPGT&RA Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
09426208877 |
| Fax |
|
| Email |
drhmchandola@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr A R Dave |
| Designation |
Associate professor |
| Affiliation |
Institute for post graduation training and research in ayurveda |
| Address |
Department of kayachikitsa IPGT&RA Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
09824171817 |
| Fax |
|
| Email |
alankruta@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Institute for post graduation training and research in ayurveda
Gujarat Ayurved University
JAMNAGAR 361 008
Gujarat India |
|
|
Primary Sponsor
|
| Name |
Institute for post graduation training and research in ayurveda |
| Address |
Gujarat Ayurved University
JAMNAGAR 361 008
Gujarat 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 Shivam Joshi |
Department of kaya chikitsa |
Institute for post graduate training and research in ayurved
Gujarat Ayurved University,
JAMNAGAR- 361 008,
Gujarat, India
Jamnagar
GUJARAT |
09427230432
ayuholistichealth@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Institute for post graduation teaching and research in ayurved Gujarat ayurved university Jamanagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Dyslipidemia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Asanadi Ghanavati |
2 tab (each tab.contains 500mg ) TDS at morning and before food with luke warm water for 8 weeks |
| Comparator Agent |
Gomutra haritaki vati |
2 tab(each tab contains 500mg) TDS at morning and before food with luke warm water for 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Elevated levels of Serum cholesterol {201mg/dl or more} and/or
Elevated S.triglycerides {151mg/dl or more} and/or
Elevated S.LDL {131mg/dl or more} and/or
Elevated S.VLDL {41mg/dl or more}
|
|
| ExclusionCriteria |
| Details |
Patients suffering from type 1 Diabetes mellitus
Drug induced Hyperlipidemia
Systemic illness like TB,CA, Advanced stage of DM and endocrine disorders.
CNS disorder e.g.encephalopathy
|
|
|
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
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Weight reduction
lightness of body
|
upto present study ( 4 weeks ) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| GIT problem reduced markedly |
upto present study (4 weeks) |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 1 |
|
Date of First Enrollment (India)
|
13/10/2011 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized parallel clinical study to compare the effect of Asanadi ghanavati and Gomutra haritaki vati.
Asanadi ghanavati made from Asanadi gana,which is described in Astang hridaya sutra sthan adhyaya-15.
Gomutra haritaki is reference of Astang hridaya chikitsa sthan adhyaya -8
Patients were assessed before and after treatment by laboratory parameters -lipid profile. |