| CTRI Number |
CTRI/2025/10/096462 [Registered on: 24/10/2025] Trial Registered Prospectively |
| Last Modified On: |
24/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurveda treatment for management of Gouty Arthritis |
|
Scientific Title of Study
|
A Conceptual study on Trisutra Ayurveda with special reference to Vatarakta and Its Management through Vatsadani Kwatha |
| 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 Anita |
| Designation |
PG Scholar Samhita Siddhanta |
| Affiliation |
Rajarajeswari Ayurvedic Medical College |
| Address |
Room No.03, Department of Samhita Siddhanta, Rajarajeswari Ayurvedic Medical College Hospital and PG Centre Humnabad,585330. Room No.03, Department of Samhita SiddhantaRajarajeswari Ayurvedic Medical College Hospital and PG Centre Humnabad,585330. Bidar KARNATAKA 585330 India |
| Phone |
8105188789 |
| Fax |
|
| Email |
anitakoutge@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ravindar Korede |
| Designation |
Professor |
| Affiliation |
Rajarajeswari Ayurvedic Medical College |
| Address |
Dept of PG Studies in Ayurveda Samhita Siddhanta.Rajarajeswari Ayurvedic Medical College Hospital and PG Centre Humnabad,585330. Rajarajeswari Ayurvedic Medical College Hospital and PG Centre Humnabad,585330. Bidar KARNATAKA 585330 India |
| Phone |
9440316788 |
| Fax |
|
| Email |
ravindarkorede@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Ravindar Korede |
| Designation |
Professor |
| Affiliation |
Rajarajeswari Ayurvedic Medical College |
| Address |
Dept of PG Studies in Ayurveda Samhita Siddhanta.Rajarajeswari Ayurvedic Medical College Hospital and PG Centre Humnabad,585330. Rajarajeswari Ayurvedic Medical College Hospital and PG Centre Humnabad,585330. Bidar KARNATAKA 585330 India |
| Phone |
09440316788 |
| Fax |
|
| Email |
ravindarkorede@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajarajeswari Ayurvedic Medical College Hospital and PG Centre Humnabad,585330. |
|
|
Primary Sponsor
|
| Name |
Dr Anita |
| Address |
Rajarajeswari Ayurvedic Medical College Hospital and PG Centre Humnabad,585330. |
| 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 Anita |
Rajarajeswari Ayurvedic Medical College and Hospital |
Room No.03, Department of Samhita Siddhanta, Rajarajeswari Ayurvedic Medical College Hospital and PG Centre Humnabad,585330. Bidar KARNATAKA |
08105188789
anitakoutge@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Rajrajeswari Ayurvedic medical college,Hospital and PG Centre Humnabad.Karnataka |
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: Vatsadani Kwatha, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -Sukoshna Jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects having classical signs and symptoms of Vatarakta. Like Sandhi shula, Vidaha, Sandhi shooth, Sparsha asahatva, Twak vaivarnata
2. Subjects in the age group between 20-60years of either gender.
3. Subjects having serum uric acid level more than 6mg/dl to 8mg/dl.
|
|
| ExclusionCriteria |
| Details |
1. Subjects not having classical sign and symptoms of Vatarakta.
2. Subjects below age of 20years and above 60years of either gender.
3. Pregnant and Lactating mother
4. Subjects having Serum uric acid level less than 6mg/dl and above 8mg/dl
5. Subjects having malignant disorders/any systemic disorder like DM, HTN etc
6. Any other inflammatory joint disorders like tubercular arthritis and joint injuries etc.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| relief of symptoms of Vatarakta |
7th day,14th day,21th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Non recurrence of symptoms of Vatarakta. |
21st Day |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
04/11/2025 |
| 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="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
|
Ayurveda the age-old science of life is suitably
explained through the enriched concept of Trisutra1 Ayurveda in a
nut shell. i.e. Hetu, Linga, Aushada respectively. Hétu comprises of current
and distant causative factors, Linga indicates clinical features of both
healthy and diseased individuals, and Aushada consists of wholesome diet and
mode of life too. Proper, systemic understanding of this concept enables an
individual to reveal, explore and evaluate the findings in a scientific way to
the fraternity of Ayurveda.
Vatarakta is a disease produced with ‘Khavaigunya’ of
raktavahasrotas2 which includes vitiated Vata and Rakta, caused by Sanatarpana
janya nidanas3. It usually starts from small joint and associated with sandhi shoola,
sandhi shootha, vidaha, sparsha asahatva, twak vivarnata4 etc. It is usually compared with Gouty Arthritis mainly due to incomplete protein metabolism and excess
production of uric acid and reduced renal clearance of uric acid increases
these levels in blood will be deposited in the small joints of feet and hands
causes Gouty arthritis5. Recent reports of the prevalence and incidence of gout vary widely and
its between prevalence of <1% to 6.8% and an incidence of 0.58-2.89 per 1000
person-years6.
There are different
treatment modalities are explained for vatarakta such as shodhana and shamana. Vatsadani
kwatha7 is one among the drugs used in vatarakta, which consists of Guduchi
and Guggulu, Guduchi having Tikta and Kashaya rasa, laghu guna, ushna virya, Madhura
vipaka, and acts as tridoshashamaka, balya, dipana, rasayana, and jwaraghna8.
Guggulu having Katu Tikta and Kashaya rasa, Katu vipaka, ushna virya, and
tridoshahara properties9. They are non-controversial, easily
available and cost effective. Here
an attempt is being made to understand the literary aspect of disease thoroughly
both Ayurveda and modern lines though the application of Trisutra Ayurveda to
afford a proper treatment modality to the ailing society is the real need of
the hour. |