| CTRI Number |
CTRI/2025/04/083918 [Registered on: 02/04/2025] Trial Registered Prospectively |
| Last Modified On: |
29/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Assessing the effect of kokilaksha kashaya with and without kaishora guggulu in the management of vatarakta with specific reference to Gouty Arthritis;A randomised clinical trail. |
|
Scientific Title of Study
|
An open lebel comparative clinical study to evaluate the effect of kokilaksha kashaya with and without kaishora guggulu in the management of vatarakta with specific 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 |
Dr Jyoti Maruti Sayanak |
| Designation |
Post graduation Resident |
| Affiliation |
Dhanwantari Ayurveda College Hospital and PG Research Centre Siddapur |
| Address |
Department of Kayachikitsa; Dhanwantari Ayurveda College Hospital and PG Research Centre Siddapur
Department of Kayachikitsa; Dhanwantari Ayurveda College Hospital and PG Research Centre Siddapur
Uttara Kannada
KARNATAKA
581355
India |
| Phone |
8123213875 |
| Fax |
|
| Email |
jyotisayanak6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Roopa Bhat |
| Designation |
Professor and H.O.D Dept.of P.G Studies in Kayachikitsa |
| Affiliation |
Dhanwantari Ayurveda College Hospital and PG Research Centre Siddapur |
| Address |
Department of P.G Studies in katachikitsa;
Dhanwantari Ayurveda College Hospital and PG Research Centre Siddapur
Department of P.G studies in katachikitsa;
Dhanwantari Ayurveda College Hospital and PG Research Centre Siddapur
Uttara Kannada
KARNATAKA
581355
India |
| Phone |
9845301333 |
| Fax |
|
| Email |
ayurroopa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Roopa Bhat |
| Designation |
Professor and H.O.D Dept.of P.G Studies in Kayachikitsa |
| Affiliation |
Dhanwantari Ayurveda College Hospital and PG Research Centre Siddapur |
| Address |
Department of P.G studies in katachikitsa;
Dhanwantari Ayurveda College Hospital and PG Research Centre Siddapur
Department of P.G studies in Katachikitsa;
Dhanwantari Ayurveda College Hospital and PG Research Centre Siddapur
Uttara Kannada
KARNATAKA
581355
India |
| Phone |
9845301333 |
| Fax |
|
| Email |
ayurroopa@gmail.com |
|
|
Source of Monetary or Material Support
|
| DHANWANTARI AYURVEDIC COLLEGE, HOSPITAL AND PG RESEARCH CENTRE SIDDAPUR UTTAR KANNADA 581355 |
|
|
Primary Sponsor
|
| Name |
DR JYOTI MARUTI SAYANAK |
| Address |
DHANWANTARI AYURVEDIC COLLEGE, HOSPITAL AND PG RESEARCH CENTRE SIDDAPUR UTTAR KANNADA DISTRICT KARNATAKA 581355 |
| 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 |
| Dr Jyoti Maruti Sayanak |
Dhanvantari Ayurveda College Hospital and PG Research Centre Siddapur |
Department of P.G studies in Kayachikitsa; Dhanvantari Ayurveda College Hospital and PG Research Centre Siddapur Uttara Kannada District 581355
Uttara Kannada
KARNATAKA |
8123213875
jyotisayanak6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Dhanvantari Ayurveda College, Hospital and Research Centre Siddapur Uttara Kannada District |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:7||Osteopathic. Ayurveda Condition: Gout , |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kokilaksha kashaya , Reference: Ashtanga hridaya Chikitsa sthana 22/18, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -ushna jala), Additional Information: -comparative study Group A -20ml kokilaksha kashaya with kaishor Guggulu 500mg will be given.
Group B only 20ml kokilaksha Kashaya will be given. | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kokilaksha kashaya , Reference: Ashtanga hridaya, Chikitsa sthana 22/18, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -ushna jala), Additional Information: -(2) Medicine Name: Kaishor Guggulu , Reference: Sharangadhara samhita madyama khanda 7/70-81, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -ushna jala ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having cardinal signs and symptoms of Vatarakta are Sandi Shoola, Sandi Shotha, Vaivarnya, Sthambana, Chimchimayana, Sheeta pradwesha, Ugradaha, Sankoch of dhamani, anguli and Sandi.
2.On irregular medications and irrespective of discrimination of race, religion and sex.
3.Patients fulfilling the diagnostic criteria of Vatarakta preferred serum uric acid above 7.5mg/dl to 15mg/dl. |
|
| ExclusionCriteria |
| Details |
1.patients with diabetes mellitus, hypertension, congenital abnormalities.
2. Unstable medical or psychiatric illness.
3 history of seizures.
4. Pregnant women, lactating mother and alcoholic.
5 symptoms suggestive of Vatavyadhi other than Vatarakta.
6.Vatarakta with Upadrava.
7. Patient having serum uric acid less than 3.5 mg/dl and more than 15mg/dl |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in sandishoola/severity of joint pain measuredwith VAS Scale
Reduction in Sandi Shotha measured in cms
Improvement in the range of movements of joints measured with Goniometer reading |
1st day i.e before treatment, 15th day after giving treatment and on 30th day i.e 4 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in the overall signs and symptoms of Vatarakta and improvement in the quality of life. |
1st day i.e before treatment
Follow up 15th day after treatment and on 31 st day after treatment |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
20/04/2025 |
| 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)
|
Not Yet Recruiting |
| 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
|
Management of Vatarakta (Gouty Arthritis) in the age group 16 to 60 yrs. 40 patients diagnosed with Vatarakta Will be divided into two groups of 20 patients. Kokilaksha kashaya 20ml and Kaishor Guggulu 500mg along with luke warm water will be given twice a day for 30days to Goup A patients internally and For Group B only Kokilaksha kashaya 20ml along with luke warm water twice a day will be given for 30 days. Patients will be assessed for primary outcome reduction in Sandhishoola, Sandhishotha and improvement in range of movements. Secondary outcome measure will be improvement in overall signs and symptoms of vatarakta and improvement of quality of life of the patient. grading will be given for subjective and objective criteria after the assessment on 1stday-before the treatment , 15th day-after the treatment and follow up will be done on 31stday . The data obtained will be analysed statistically with suitable method. |