| CTRI Number |
CTRI/2026/03/106258 [Registered on: 16/03/2026] Trial Registered Prospectively |
| Last Modified On: |
13/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To examine the effectiveness of Ajamodadi Vati in the management of Vatarakta with special reference to gouty arthritis |
|
Scientific Title of Study
|
A randomised controlled clinical trial to evaluate the efficacy of ajamodadi vati in the management of vatarakta with special reference 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 |
Vd Nishikant Badrinath Jadhav |
| Designation |
PG Scholar, MD Kayachikitsa |
| Affiliation |
Late Kedari Redekar Ayurved Mahavidyalaya and PG Training and Research Center, Gadhinglaj. |
| Address |
Department of Kayachikitsa, OPD no.2, Ground floor, LKR Hospital, P-2 MIDC Area, Shendri Mal, Gadhinglaj, Dist - Kolhapur
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9763963638 |
| Fax |
|
| Email |
jadhavnishikant1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Viraj Vinayak Shukla |
| Designation |
Professor and HOD of Kayachikitsa Department |
| Affiliation |
Late Kedari Redekar Ayurved Mahavidyalaya and PG Training and Research Center, Gadhinglaj |
| Address |
Deapartment of Kayachikitsa, OPD no.2, Ground floor, LKR Hospital, P-2 MIDC Area, Shendri Mal, Gadhinglaj, Dist - Kolhapur
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9822936193 |
| Fax |
|
| Email |
rajvishukla@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Nishikant Badrinath Jadhav |
| Designation |
PG Scholar, MD Kayachikitsa |
| Affiliation |
Late Kedari Redekar Ayurved Mahavidyalaya and PG Training and Research Center, Gadhinglaj. |
| Address |
Department of Kayachikitsa, OPD no.2, Ground floor, LKR Hospital, P-2 MIDC Area, Shendri Mal, Gadhinglaj, Dist - Kolhapur
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9763963638 |
| Fax |
|
| Email |
jadhavnishikant1997@gmail.com |
|
|
Source of Monetary or Material Support
|
| Late Kedari Redekar Ayurved Mahavidyalaya and PG Training and Research Center Gadhinglaj P-2 MIDC Area, Shendri Mal, Gadhinglaj.Dist-Kolhapur |
|
|
Primary Sponsor
|
| Name |
Vd Nishikant Badrinath Jadhav |
| Address |
Late Kedari Redekar Ayurved Mahavidyalaya and PG Training and Research Center Gadhinglaj P-2 MIDC Area, Shendri Mal, Gadhinglaj.Dist-Kolhapur-416502, India. |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Vd Nishikant Badrinath Jadhav |
Late Kedari Redekar Ayurved Mahavidyalaya and Hospital Gadhinglaj |
Kayachikitsa OPD, Ground floor, LKR Hospital, P-2 MIDC Area, Shendri Mal, Gadhinglaj-416502 Kolhapur, MAHARASHTRA
Kolhapur
MAHARASHTRA |
9763963638
jadhavnishikant1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Late Kedari Redekar Ayurved Mahavidyalaya and PG Training and Research Center Gadhinglaj |
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: Ajamodadi vati, Reference: Bharat bhaishajya ratnakar , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 4(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -koshna jala ), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Amrutadi guggul vati , Reference: Bharat bhaishajya ratnakar , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 4(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -gud ( jaggery)), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients irrespective of gender, patients with age between 20 years upto 60 years, Patients with elevated serum uric acid levels upto 6 to 10 mg/dl, CRP level above 6 mg/L,Signs and symptoms of Vatarakta like parvasandhi shool (pain in distal phalenges),parvasandhi shoth(swelling)
todavat vedana(pricking pain), sparsh asahtva
(tenderness),raga(redness),dah(burning sensation) |
|
| ExclusionCriteria |
| Details |
Patients with other major illness like diabetes mellitus, hypothyroidism, hyperthyroidism, hypertension, HIV, cancer, chronic kidney disease
Patients with serum uric acid level above 10 mg/dl will be excluded, those patients who are not willing to give consent, Pregnant women and lactating womens, patients with age below 20 years and age above 60 years are excluded
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of ajamodadi vati in the management of vatarakta |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of ajamodadi vati and amrutadi guggul vati in the management of vatarakta with special reference to gouty arthritis |
21 days |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
28/03/2026 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This study is a randomised controlled clinical trial to evaluate the efficacy of ajamodadi vati in the management of vatarakta with special reference to gouty arthritis. After screening patients at OPD level 60 patients will be randomly selected irrespective of gender within the age between 20 years to 60 years and further divides into 2 groups of 30 patients each. Before starting trial informed written consent will be taken in participants native language.
Trial group - Ajamodadi vati 4 gram TDS orally for 21 days Control group - Amrutadi guggul vati 4 gram TDS orally for 21 days
Assessment will be done on the basis of subjective parameters ( parva sandhi shoth, sparsh asahatva, dah, parva sandhi shool, twak vivarnata ) and objective parameters ( serum uric acid and CRP ) at baseline and 7th, 14th and 21th day. Data will be analysed and appropriate statistical test will be applied and result will be presented |