| CTRI Number |
CTRI/2025/01/079031 [Registered on: 20/01/2025] Trial Registered Prospectively |
| Last Modified On: |
31/05/2026 |
| 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
|
A clinical study to compare the efficacy of Guduchi Ghanavati with Bodhivriksha Kashaya in Vatarakta w.r.t. Gouty Arthritis. |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the efficacy of Guduchi Ghanavati and Bodhivriksha Kashaya in Vatarakta w.s.r. to Gouty Arthritis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Naidu Jaganath |
| Designation |
PhD Scholar-Kayachikitsa |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research Hospital, Sri Sri University,Cuttack |
| Address |
Department of Kayachikitsa, Sri Sri College of Ayurvedic Science and Research Hospital, Sri Sri University,Cuttack, Odisha.
Staff quarter no.1, SSN Ayurvrd College and RI, Nrusinghnath, Paikmal,Bargarh,Odisha.
Cuttack
ORISSA
754006
India |
| Phone |
09437616704 |
| Fax |
|
| Email |
jaganath.drnaidu13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof. (Dr). Nagendra Prasad |
| Designation |
Professor and Head |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research Hospital, Sri Sri University,Cuttack |
| Address |
Dept. of Shareera Kriya Vijnana (SKV), Sri Sri College of Ayurvedic Science and Research Hospital, Sri Sri University,Cuttack, Odisha.
Cuttack
ORISSA
754006
India |
| Phone |
9743634751 |
| Fax |
|
| Email |
drprasadng@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Naidu Jaganath |
| Designation |
PhD Scholar-Kayachikitsa |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research Hospital, Sri Sri University,Cuttack |
| Address |
Dept. of Kayachikitsa, Sri Sri College of Ayurvedic Science and Research Hospital, Sri Sri University,Cuttack, Odisha.
Staff Quarter No.1, SSN Ayurvrd College and RI,Nrusinghnath, Paikmal,Bargarh,Odisha.
Cuttack
ORISSA
754006
India |
| Phone |
9437616704 |
| Fax |
|
| Email |
jaganath.drnaidu13@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.Naidu Jaganath, PhD Scholar
Dept. of Kayachikitsa, Sri Sri College of Ayurvedic Science and Research Hospital, Sri Sri University, Cuttack, Odisha, india, Pin 754006 |
|
|
Primary Sponsor
|
| Name |
Sri Sri College of Ayurvedic Science and Research Hospital, |
| Address |
Sri Sri University,Cuttack,Odisha |
| 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 Naidu Jaganath |
Dr.K.S.Bhoi Ayurved Chikitsalaya |
Dept. of Kayachikitsa, SSN Ayurved College & RI, At-Nrusinghnath,Paikmal.
Bargarh
ORISSA |
9437616704
jaganath.drnaidu13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe(IEC) for Biomedical Research of Faculty of Health & Wellness ,Sri Sri College of Ayurvedic Science and Research Hospital, Sri Sri University, Cuttack. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M109||Gout, unspecified. Ayurveda Condition: VATARAKTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Guduchi, Reference: Charak samhita Chikitsa Sthanam 29/158 and Astanga Hriday Uttartantra- 40 / 50, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Warm Water), Additional Information: The drug will be prepared in a GMP certified Pharmacy | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Bodhivriksha Kashaya, Reference: Dr. K. M. Bhavana, Dr. Umesh C, Dr. Neelakanta Sajjanar, Dr. Gopala Krishna G. A Randomized Comparative Clinical Study to evaluate the effect of Bodhi Vruksha Twak Kashaya with Madhu and Guduchi Kashaya in the Management of Vatarakta with special reference to Gouty Arthritis. J Ayurveda Integr Med Sci 2020;2:22-29. http://dx.doi.org/10.21760/jaims.5.2.4, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Honey-3gm), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients suffering from Vatarakta(Gouty Arthritis) with sign and symptoms like Sandhi shoola(Pain in affected Joints), Daha(Burning Sensation) Sandhi Shotha(Inflammation), Vaivarnata(discolouration) Sparshsahatwa(Tendernaess) along with hyperuricemia will be included in the study.
A serum Uric acid(urate) level more than 6.8 mg/dl will be defined as hyperuricemia. |
|
| ExclusionCriteria |
| Details |
•Known case of HIV patients or subjects on immune suppressive drugs.
•Known cases of diabetes mellitus, hypertension, heart diseases, and cancer.
•Pregnant and lactating females,
•Known cases of Rheumatoid Arthritis.
•Known cases of Osteoarthritis.
•Patients taking anti-tubercular drugs.
•Known case of renal and liver disorder.
•Obesity.
•Known cases of Hypothyroidism/Thyrotoxicosis
•Known cases of anaemia.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Guduchi Ghanavati is more effective than Bodhivriksha Kashaya in alleviating the sign and symptoms of Vatarakta (Gouty Arthritis) and lowering the uric acid level. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Guduchi Ghanavati will act more effectively than Bodhivriksha Kashaya in reducing pain and inflammation in affected joint along with lowering serum uric acid level. |
3 months |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
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 3 |
|
Date of First Enrollment (India)
|
01/02/2025 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
·
After review of previous studies it was observed that some formulations
have been established to restrict the progression of Vatarakta (Gouty arthritis) with
certain limitations.
·
The requirement of a non-toxic, potent, cost
effective, easily available, easy to take and palatable Vataraktahara drug having uricosuric effect is still required.
Therefore in this study
an attempt will be made to establish the efficacy of Guduchi Ghanavati in the management of Vatarakta (Gouty arthritis). |