| CTRI Number |
CTRI/2020/03/024025 [Registered on: 18/03/2020] Trial Registered Prospectively |
| Last Modified On: |
07/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic
Preventive
Screening |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Management of Gridhrasi with Vatari Guggulu |
|
Scientific Title of Study
|
Etiopathological study of Vata Kaphaja Gridhrasi And its Management with Vatari Guggulu |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hetal Patel |
| Designation |
MD Ayurveda Scholar of Roga Nidan evum Vikriti Vigyan |
| Affiliation |
Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar |
| Address |
Room No 515 Department of Roga Nidan evum Vikriti Vigyan Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar Gujarat
Jamnagar
GUJARAT
361008
India |
| Phone |
9409557105 |
| Fax |
|
| Email |
phetal124.ph@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Darshna Pandya |
| Designation |
Assistant Professor of Roga Nidan evum Vikriri Vigyan |
| Affiliation |
Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar |
| Address |
Room No 515 Department of Roga Nidan evum Vikriti Vigyan Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar Gujarat
Jamnagar
GUJARAT
361008
India |
| Phone |
9099011095 |
| Fax |
02882676856 |
| Email |
darshnapandya@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Darshna Pandya |
| Designation |
Assistant Professor of Roga Nidan evum Vikriri Vigyan |
| Affiliation |
Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar |
| Address |
Room No 515 Department of Roga Nidan evum Vikriti Vigyan Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar Gujarat
Jamnagar
GUJARAT
361008
India |
| Phone |
9099011095 |
| Fax |
02882676856 |
| Email |
darshnapandya@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Opp City B division police station PN marg Jamnagar 361008 Gujarat |
|
|
Primary Sponsor
|
| Name |
Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University |
| Address |
Gujarat Ayurved University Opp City B division police station PN marg Jamnagar 361008 Gujarat |
| 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 |
| Hetal Patel |
Institute for Post Graduate Teaching and Research in Ayurveda hospital |
OPD no 16 Department of Roga Nidan Evum Vikriti Vigyan Institute for Post Graduate Teaching and Research in Ayurveda hospital Gujarat Ayurved University opposite city B division police station PN marg Jamnagar 361008
Jamnagar
GUJARAT |
9409557105
phetal124.ph@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G541||Lumbosacral plexus disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Vatari Guggulu |
Vatari Guggulu will be given in the patients of Vatakaphaja Gridhrasi 3 Tab of 500 mg each twice with lukewarm water before meal for 1 month |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient having cardinal symptoms of Vata Kaphaja Gridhrasi like Ruka Toda Stambha Spandana Aruchi Tandra Gaurava along with positive SLR test
Patients willing to participate in study
|
|
| ExclusionCriteria |
| Details |
Age below 20 and above 60 years Patients suffer from any other systemic disorders
Spinal deformity Spinal tumor Traumatic injury to spine congenital spine deformity
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study etiological factors of Vata Kaphaja Gridhrasi in present era dietetics life style |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Vatari Guggulu in the management of Vata Kaphaja Gridhrasi |
1 month |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "15"
Final Enrollment numbers achieved (India)="15" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/04/2020 |
| Date of Study Completion (India) |
31/05/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
To evaluate causative factors of the Grihrasi total 46 patients was surveyed (snap shot survey) and out of them 15 patients between age group of 20-60 years having the complaints of Vata Kaphaja Gridhrasi were enrolled for the clinical trial and 3 tablet BD (500mg each) of Vatari Guggulu was given with luke warm water before meal for 1 month orally. The obtained data was analyzed for statistical significance using Wilcoxon signed rank test for subjective parameter and paired t test . The result was interpreted as, insignificant p>0.05, significant p<0.05, highly significant p<0.01 and very highly significant p<0.001.100% relief was found in Tandra, Gaurava and Aruchi followed by Stambha (88.9%), Spandana (66.7%), Toda (76.9%), Ruka (48.6%) and SLR (31.43%). Tandra, Gaurava , Stambha Ruka and SLR was statistically very highly significant. Aruchi was statistically highly significant. Toda and Spandana statistically significant. An Ayurveda treatment protocol i.e. Vatari Guggulu is effective in the management of Vata Kaphaja Gridhrasi. |