| CTRI Number |
CTRI/2021/10/037157 [Registered on: 07/10/2021] Trial Registered Prospectively |
| Last Modified On: |
06/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
"Study Of Guggul Vatika And Kaishor Guggul In Vatarakta" |
|
Scientific Title of Study
|
"Randomized Control Clinical Trial Of Efficacy Of Guggul Vatika In Vatarakta" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Snehal Shivaji kamble |
| Designation |
PG Scholar Kayachikitsa |
| Affiliation |
Hon Shri Annasaheb Dange Ayurvedic Medical College And Post Graduate Research Centre Ashta, |
| Address |
Hon Shree Annasaheb Dange Ayurved Medical College And Post Graduate Research Centre Ashta, Sangli
Hon Shree Annasaheb Dange Ayurved Medical College And Post Graduate Research Centre Ashta, Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9075944155 |
| Fax |
|
| Email |
snehalkamble4055@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Dattatrya Nikam |
| Designation |
Associate Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurvedic Medical College And Research Centre Ashta |
| Address |
Hon Shri Annasaheb Dange Ayurvedic Medical College And Research Centre Ashta Tal-walwa Dist- sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
8390761674 |
| Fax |
|
| Email |
drdattatryanikam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Snehal shivaji kamble |
| Designation |
PG scholar Kayachikitsa |
| Affiliation |
Hon Shri Annasaheb Dange Ayurvedic Medical College And Post Graduate Research Centre Ashta, |
| Address |
Hon Shri Annasaheb Dange Ayurvedic Medical College And Research Centre Ashta
Hon Shri Annasaheb Dange Ayurvedic Medical College And Research Centre Ashta
Sangli
MAHARASHTRA
416301
India |
| Phone |
9075944155 |
| Fax |
|
| Email |
snehalkamble4055@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dhanwantari Hospital,Kayachikitsa OPD Ashta. |
|
|
Primary Sponsor
|
| Name |
Hon Shri Annasaheb Dange Ayurvedic Medical College And Research Centre Ashta |
| Address |
Hon Shri Annasaheb Dange Ayurvedic Medical College And Research Centre Ashta Dist Sangli |
| Type of Sponsor |
Private 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 |
| Snehal Shivaji kamble |
Dhanwantari Hospital Ashta |
Dhanwantari Hospital, Kayachikitsa OPD, Ashta
Sangli
MAHARASHTRA |
9075944155
snehalkamble4055@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:M109||Gout, unspecified. Ayurveda Condition: Vatvyadhi Avaranjanya, (2) ICD-10 Condition:M100||Idiopathic gout. Ayurveda Condition: VATARAKTAM, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Guggul vatika 500 mg BD |
Guggul Vatika 500 mg BD Orally with Honey for 21 Days |
| Comparator Agent |
Kaishor guggul 500 mg BD |
Kaishor Guggul 500mg BD Orally With lukewarm water For 21 Days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient with Classical Signs And Symptoms Of Vatarakta ,Sandhishul,Daha,sandhishotha, Sparshasahatva,aaraktavarnata.
hyperuricemia(above 6.8 mg/dl to 10.0) with symptoms of gout.
|
|
| ExclusionCriteria |
| Details |
Patients associated with Metabolic disorders and other systemic.
patient with autoimmune disease.
Patient who are on regular NSAIDS and Steroidal anti-inflammatory drug |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study efficacy of Kaishor guggul and Guggul Vatika in Vatarakta |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Characteristic of Guggul vatika and Kaishor Guggul in Vatarakta |
18 months |
|
|
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 4 |
|
Date of First Enrollment (India)
|
12/10/2021 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
According to clinical features Vatarakta can be compared with Gout.It is more common inflammatory arthritis caused by mono sodium urate monohydrate crystals in and around synovial joints. It is Characterized by severe pain, redness and tenderness in joints. The prevalence of gout is 0.1% in Maharashtra and is increases more. In 21st Century , the management of vatarakta is challenging, as it is the disease of severe morbidity and Chronicity. In modern Medicine there are limitations in treatment of Vatarakta and there are so many side effects. hence in ayurveda guggul Vatika is stated for Vatarakta by Bhavaprakash. It contains Guggulu And Guduchi have common properties of Rasashodhan, Vatashaman, Guduchi is the Vyadhipratyanik drug for Vatarakta. Hence the topic Chosen to study guggulvatika in Vatarakta |