| CTRI Number |
CTRI/2015/07/006004 [Registered on: 15/07/2015] Trial Registered Prospectively |
| Last Modified On: |
25/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical study of two source plants of Shalparni in Vatarakta |
|
Scientific Title of Study
|
A Pharmacotherapeutical study of two source plants of Shalparni Desmodium gangeticum DC and Desmodium laxiflorum DC 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 |
Suman Singh |
| Designation |
PhD Scholar |
| Affiliation |
Institute for Post Graduate Teaching and Research in Ayurveda |
| Address |
Dravyaguna Department Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar GUJARAT 361008 India
Dravyaguna Department Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar GUJARAT 361008 India
Jamnagar
GUJARAT
361008
India |
| Phone |
9510172204 |
| Fax |
|
| Email |
snghsmn@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr B R Patel |
| Designation |
Assistant lecturer Dravyaguna department |
| Affiliation |
Institute for Post Graduate Teaching and Research in Ayurveda |
| Address |
Dravyaguna Department Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar GUJARAT 361008 India
Dravyaguna Department Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar GUJARAT 361008 India
Jamnagar
GUJARAT
361008
India |
| Phone |
9427574590 |
| Fax |
|
| Email |
brp_1967@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr B R Patel |
| Designation |
Assistant lecturer Dravyaguna department |
| Affiliation |
Institute for Post Graduate Teaching and Research in Ayurveda |
| Address |
Dravyaguna Department Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar GUJARAT 361008 India
Dravyaguna Department Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar GUJARAT 361008 India
Jamnagar
GUJARAT
361008
India |
| Phone |
9427574590 |
| Fax |
|
| Email |
brp_1967@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Teaching Hospital Gujarat Ayurveda University Jamnagar |
|
|
Primary Sponsor
|
| Name |
Institute for Post Graduate Teaching and Research in Ayurveda |
| Address |
Depatment of Dravyaguna Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurveda University Jamnagar 361008 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 Suman Singh |
IPGTRA GAU Jamnagar |
OPD No. 17 Department of Dravyaguna
Jamnagar
GUJARAT |
9510172204
snghsmn@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
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M148||Arthropathies in other specified diseases classified elsewhere, early symptoms and symptoms of vatarakta gout, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Shalparni Desmodium gangeticum |
orally kwath 24ml bd
before food with milk for 4 weeks follow up 2 weeks |
| Comparator Agent |
Shalparni species Desmodium laxiflorum |
orally kwath 24 ml bd before food with milk for 4 weeks follow up 2 weeks |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with the classical signs and symptoms of purvarupa early symptoms and rupa symptoms of Vatarakta gout
Patients having classical signs and symptoms with less than 1year chronicity
|
|
| ExclusionCriteria |
| Details |
• Patients below 16 and above 70 years of age.
Patients having chronicity more than 1year and of Gambhir Vatarakta deep seated gout
Patients suffering from any systemic diseases like Diabetes Hypertension Cardiac anomaly Chronic renal failure Liver cirrhosis
Pregnant or lactating mother
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
change in clinical symptoms of Vatarakta gout
Episodes of joints Pain
Burning sensation in joints
Parasthesia of joints
Discolouration on Joints
Fatigue
|
4 weeks study and 2 weeks follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| changes in Biochemical heamatological parameters |
4 weeks study and 2 weeks follow up |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
21/10/2015 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Shalaparni
is one of the contents of Dashamoola, a widely used combination in Ayurveda. Acharya Charaka has
delineated, Shalaparni as a single drug in the management of Vatarakta.
So, keeping this in view, present study was carried out to evaluate comparative
therapeutic effect of Desmodium gangeticum and Desmodium laxiflorum
in purvarupa and rupa of Vatarakta
Total 66 patients
were registered in the clinical study. 30 patients in group-A and 31 patients
in group-B were completed in the study. After completion of the study and statistical
analysis unveiling of the blinding was done.
In comparative effect Group B (D.gangeticum) produced better
results in Sandhishoola Ruk bhutva-Bhutva Nistoda and Sadanam
whereas better result in Daha and Sphuran-ayama were observed in Group
A. In bio-chemical parameters Group B (D.gangeticum) was better in S. cholesterol, S. HDL Uric
acid and CRP whereas Group A (D.laxiflorum) produced better result on S.
Triglycerides.
In Group A (D.laxiflorum)
out of 30 completed patients, 80% were mildly improved and 20% were moderately
improved at the end of treatment period. In Group B (D.gangeticum) out
of 31 completed patients 9.67% were unchanged, 64.51% were mildly improved and
25.80% of patients showed moderately improvement at the end of treatment
period.
|