| CTRI Number |
CTRI/2025/12/099342 [Registered on: 17/12/2025] Trial Registered Prospectively |
| Last Modified On: |
12/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effectiveness between kokilakshadi kwath ghanvati and febuxostat in the management of vatarakta with special reference to gout in the age group of 35-65 years for lowering the level of sr.uric acid and symptoms of vatarakta |
|
Scientific Title of Study
|
A randomized comparative clinical trial to evaluate the efficacy of kokilakshadi kwath ghanvati and febuxostat in the management of vatarakta with special reference to gout. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rutuja jijaba Gawade |
| Designation |
PG Scholar |
| Affiliation |
PDEAs College of Ayurveda and Research centre Nigdi Pune |
| Address |
PDEAs College of Ayurveda and Research centre Nigdi Pune
PDEAs College of Ayurveda and Research centre 3rd floor Kayachikitsa Department Nigdi pradhikaran Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
7720860669 |
| Fax |
|
| Email |
rutuja.gawade1612@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rupali Tarachand Khobragade |
| Designation |
Professor & HOD |
| Affiliation |
PDEAs College of Ayurveda and Research centre Nigdi Pune |
| Address |
PDEAs College of Ayurveda and Research centre Nigdi Pune
PDEAs College of Ayurveda and Research centre 3rd floor Kayachikitsa Department Nigdi pradhikaran Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
8378929859 |
| Fax |
|
| Email |
khobragaderupali19@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rutuja jijaba Gawade |
| Designation |
PG Scholar |
| Affiliation |
PDEAs College of Ayurveda and Research centre Nigdi Pune |
| Address |
PDEAs College of Ayurveda and Research centre Nigdi Pune
PDEAs College of Ayurveda and Research centre 3rd floor Kayachikitsa Department Nigdi pradhikaran Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
7720860669 |
| Fax |
|
| Email |
rutuja.gawade1612@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PDEAs College of Ayurveda and Research centre Nigdi Pune |
| Address |
PDEAs College of Ayurveda and Research centre Nigdi pradhikaran Pune 411044 |
| 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 |
| Dr Rutuja Jijaba gawade |
Ayurved rugnalay and snowbell multispeciality hospital nigdi pradhikaran pune |
Ayurved rugnalay and snowbell multispeciality hospital sector 27 kayachikitsa department ground floor OPD no. 117 nigdi pradhikaran pune 411044
Pune
MAHARASHTRA |
7720860669
rutuja.gawade1612@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee college of Ayurveda and Research centre Nigdi pune |
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: Kokilakshadi ghanvati, Reference: Vrundamadhav, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Tab .Febuxostat 40 mg | Tab .Febuxostat 40 mg once a day after meal with normal water. |
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.patient whose sr. Uric acid is above 6.8 gm/dl and below 9 gm/dl
2.patients have fulfilling criteria such as sandhi shool ,sandhi stabdhata ,sandhi shoth ,sandhi daha .
3.affected joint especially 1st metatarsophalengial joint other affected joints of body also will be included |
|
| ExclusionCriteria |
| Details |
1.Known case of amavata
2.known case of sandhigatavata
3.with known case of tuberculosis,HIV,trauma,cardiac disease
4.known case of peripheral vascular disease
5.pregnent and lactating women
6.habitual alcoholic patient
7.patient suffering from secondary gout |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effectiveness of kokilakshadi kwath ghanvati 500 mg vyanodan Kal with normal water for 21 days and febuxostat 40 mg once a day after meal with normal water for 21 days in the management of vatarakta with special reference to gout. |
21 days with follow up on 8th 15th 22nd day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe and compare the adverse effect in two groups within 21 days |
21 days with follow up on 8th 15th 22nd day |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
N/A |
|
Date of First Enrollment (India)
|
27/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
27/12/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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
|
Health of any individual is depend on their lifestyle.due to poor eating habits like eating junk food which are excessively spicy ,salty ,sore ,pungent ,lack of sleep,excessive travelling and physical exercise and increased exertion in a day to day life.people are more prone to disease among which vatarakta is common presentation. Due to hetu sevan vatdushti and raktdushti occurs vitiated rakata obstruct the strotasas.due to strotas obstruction, normal gate of vata is obstructed this kupit vayu again vitiate the rakta of whole sharir which leads to vatarakta Gout is inflammatory and metabolic joint disorder which is caused by deposition of monosodium urate crystal in joints and soft tissues following chronic hyperuricemia. Kokilakshadi kwath is mentioned in vrundmadhav having all properties may reverse the pathogenesis of vatarakta. Febuxostat is xanthine oxidase inhibitor which reduces the sr. Uric acid. |