| CTRI Number |
CTRI/2026/02/105086 [Registered on: 27/02/2026] Trial Registered Prospectively |
| Last Modified On: |
25/02/2026 |
| 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 Effect Of Kaishora Guggulu In Vatarakta (Gout) With Investigation Of Serum Uric Acid. |
|
Scientific Title of Study
|
Randomized controlled clinical trial to study effect of Kaishora Guggulu in vatarakta (Gout) with special reference to serum uric acid. |
| Trial Acronym |
vatarakta |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Snehal Uttamrao Ranvir |
| Designation |
PG scholar |
| Affiliation |
LRP Ayurvedic Medical College and Hospital, Post Graduate Institute and Research Center Islampur |
| Address |
LRP Ayurvedic Medical College and Hospital PG Institute and Research Centre Islampur, Department of Rognidan, Division No.1, Room
no 1 tq. Walwa Dist. Sangli
LRP Ayurvedic Medical College and Hospital PG Institute and Research Centre Islampur, Department of Rognidan, Division No.1, Room
no 1 tq. Walwa Dist. Sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
8552871321 |
| Fax |
|
| Email |
snehalranvir1995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gauri Atmaram Mulik |
| Designation |
Professor and HOD |
| Affiliation |
LRP Ayurvdic Medical College And Hospital Post Graduate Institute and Research Center Islampur |
| Address |
LRP Ayurvdic Medical College and Hospital, Post Graduate Institute and Research Center Islampur, Department of Rognidan, Islampur, Tal. Walwa, Dist. Sangli
LRP Ayurvdic Medical College and Hospital, Post Graduate Institute and Research Center Islampur, Department of Rognidan, Islampur, Tal. Walwa, Dist. Sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
8806073556 |
| Fax |
|
| Email |
gaurimohite492@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gauri Atmaram Mulik |
| Designation |
Professor and HOD |
| Affiliation |
LRP Ayurvdic Medical College And Hospital ,Post Graduate Institute and Research Center Islampur |
| Address |
LRP Ayurvdic Medical College and Hospital, Post Graduate Institute and Research Center Islampur, Department of Rognidan, Islampur, Tal. Walwa, Dist. Sangli
LRP Ayurvdic Medical College and Hospital, Post Graduate Institute and Research Center Islampur, Department of Rognidan, Islampur, Tal. Walwa, Dist. Sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
8806073556 |
| Fax |
|
| Email |
gaurimohite492@gmail.com |
|
|
Source of Monetary or Material Support
|
| LRP Ayurvedic Medical College and Hospital PG Institute and Research Centre Islampur, Department of Rognidan, Division No.1, Room
no 1 tq. Walwa Dist. Sangli Sangli MAHARASHTRA 415409 India |
|
|
Primary Sponsor
|
| Name |
Dr Snehal Uttamrao Ranvir |
| Address |
LRP Ayurvedic Medical College and Hospital PG Institute and Research Centre Islampur, Department of Rognidan, Division No.1, Room
no 1 tq. Walwa Dist. Sangli MAHARASHTRA 415409 India |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 0 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| LOKNETE RAJARAMBAPU PATIL AYURVEDA MAHAVIDYALAYA SANGLI INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:PCS||. Ayurveda Condition: VATARAKTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kaishora Guggulu, Reference: Shanargdhar Samhita, nadhyam khanda , chapter 7, shloka 70 to 81, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: koshna jala), Additional Information: Nil | | 2 | Comparator Arm (Non Ayurveda) | | - | Allopurinol | Nil |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patient having sing and symptoms such as Sandhishoola, Sprashasahatva,Sandhishotha
Stabdhata, Daha.
patient of either gender,irrespective of socioeconomic status
|
|
| ExclusionCriteria |
| Details |
patient below 18 years and above 60 years old.
pregnant women and lactating mother.
knowncase of HIV.
knowncase Rheumatoid arthritis, Tubercular arthritis Syphilitic arthritis, Maleria, Neurological disorder.
knowncase of chikungunya
knowncase of erythematous.
serum uric acid level more than 12mg/dl.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to study add on effect of kaishora guggulu in the management of vatarakta (gout) with special reference to serum uric acid |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To study vatarakta in detail according to ayurveda
2)To study gout in detail according to modern science
3) To study kaishora guggulu properties.
4)To study serum uric acid in
details.
5)To study effect of kaishora guggulu on sign & symptoms of vatarakta & on uric acid levels. |
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 2 |
|
Date of First Enrollment (India)
|
20/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/03/2026 |
| 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
|
vatarakta is disorder of VataDosha which is associated with DushyaRakta ,the chief complaint of patients is joint pain with onset from Hasta, Padangushtamulagata sandhi and then it migrates to other joints in a way similar to Akhuvisha.the disease which is most commonly seen in kudhavata i.e near the ankle or in smaller joints. the classical symptoms include Shvayathu, Bheda, Toda, Shoola, Sparshasahatva considering, the clinical presentation and textualreferences of the disease it can correlated with Gout explained in modern medicine Gout is the most Common type of inflammatory arthritis and is associated with impaired quality of life. the formation and deposition of monosodium urate crystals takes place in and around joints as serum uric acid level rise and the physiological saturation threshold for uric acid is exceeded in the body fluids.Clinical manifestations of monosodium urate crystals deposition include acute of attacks of severe pain and inflammation affecting peripheraljoints, most commonly the first metatarso-phalangeal joint.modern lifestyle :1diet 2 loss exercise 3 night life:Due to night vigil pitta dosha gets increased and so raktadushti occurs. symptoms:Burning sensation, pain, joint pain, tenderness of joint, inflammation of joints, stiffness of joints. analgesic and other drugs may causes hyper acidity, which can be referred as pitta doshaprakop, which can increase a raktadosha. the present study kaishora guggulu is selected for vatarakta (gout) disease it includes guggulu, amalaki, guduchi, shunthi, haritaki, maricha, pippali, trivrit, danti, vidang, Bibhataki act on vata and Pitta,kaphajdosha helps in reducing Pain and Burning sensation, anti inflammatory, immunomodulation. which is easily available, Cost effective, palatable, reliable of patients, clinical method:- trial group:kaishora guggulu 500mg BD. treatment 30 day pt 30 control group:allopurinol pts-100mg-OD treatment 30 day pt 30
|