| CTRI Number |
CTRI/2025/04/084239 [Registered on: 07/04/2025] Trial Registered Prospectively |
| Last Modified On: |
08/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Basti (Medicated Enema)] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to know the Effect of medicated enema in Gouty Arthritis |
|
Scientific Title of Study
|
A Single Arm Clinical Trial To Assess the Efficacy Of Navakarshika Ksheera Basti In Gouty Arthritis In Relation To Gout Impact Scale & Biomarker Serum-Urate Transporter 1 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sawant Sneha Dilip |
| Designation |
PG Scholar |
| Affiliation |
Amrita School Of Ayurveda |
| Address |
Department of Paanchakarma, Amrita School of Ayurveda, Amrita Vishwa vidyapeetham, Clappanna P.O. Kerala India
Kollam
KERALA
690525
India |
| Phone |
8055509099 |
| Fax |
|
| Email |
savantsneha0110@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Parmehswaran Namboothiri |
| Designation |
Head Of Department |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Department of Paanchakarma, Amrita School of Ayurveda, Amrita Vishwa vidyapeetham, Clappanna P.O. Kerala India
Kollam
KERALA
690525
India |
| Phone |
9496096694 |
| Fax |
|
| Email |
nambu24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vishnu U |
| Designation |
Associate Professor |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Department of Paanchakarma, Amrita School of Ayurveda, Amrita Vishwa vidyapeetham, Clappanna P.O. Kerala India
Kollam
KERALA
690525
India |
| Phone |
9567198958 |
| Fax |
|
| Email |
pillaidrvishnu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita School of Ayurveda, Amrita Vishwa Vidyapeetham, Clappanna P.O., Kerala, India. 690 525 |
|
|
Primary Sponsor
|
| Name |
Dr Sawant Sneha Dilip |
| Address |
Department of Panchakarma, Amrita School of Ayurveda, Amrita Vishwa Vidyapeetham, Clappanna P.O. Kerala, India. 690 525 |
| 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 Sawant Sneha Dilip |
Amrita School Of Ayurveda & Hospital |
Department of Panchakarma, Amrita School of Ayurveda, Amrita Vishwa vidyapeetham, Clappanna P.O. Kerala India 690 525
Kollam
KERALA |
8055509099
savantsneha0110@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Amrita Institutional Ethics Comittee |
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 | Procedure | - | vastikarma | (Procedure Reference: Vaidya Jädavaji Trikamji Acãrya; Caraka Samhita by Agnivesa; Revised by Caraka and Dridhabala with the Ayurveda- Dipikã commentary of Chakrapänidatta; 2014; Chapter No: 29; Vatasonita Chikitsitam; Page No: 631, Sloka No: 88., Procedure details: • Initially Sthanik Snehana-Swedana will be performed by murchita tila taila.
• Following that Participants will be administered with Navakarshika Ksheera Basti for 7 days.
• Follow up will be performed on 14th day of administration of Basti.
)
(1) Medicine Name: Navakarshika Ksheera Basti, Reference: Dr. Nirmal Saxena, Chikitsasara Samgraha of Vangasena, Text with English translation; Chaukhambha Varanasi; 2004; Vatarakta Cikitsa, Chapter 29, Page no.-459, verses- 57-59., Route: Rectal, Dosage Form: Ksheerpaka, Dose: 480(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Clinically Diagnosed of gout using ACR/EULAR gout classification criteria.
2. Subjects fit for basti karma
|
|
| ExclusionCriteria |
| Details |
1. In subjects where Chronicity of the disease is more than 6 years, associated Tophi & complete joint destruction/crippling deformity.
2. Participants suffering from severe systemic illness like uncontrolled DM, HTN, malignancy, autoimmune disease, Chronic Kidney Diseases etc.
3. Patients taking DMARDs & URAT 1 inhibitors for at least 6 days
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in GIS score |
1st, 7th & 21st day of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in Serum URAT 1 levels & Uric Acid levels |
1st, 7th & 21st day of intervention |
|
|
Target Sample Size
|
Total Sample Size="17"
Sample Size from India="17"
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 3 |
|
Date of First Enrollment (India)
|
01/06/2025 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
the protocol is proposed to assess the effect of Navakarshika Ksheera Basti in Gouty arthritis in relation to Gout Impact Scale & URAT 1 biomarker. Gout is a prevalent condition that requires effective management to improve the quality of life of affected individuals. While modern science has developed effective treatments for gout, these therapies are often associated with a range of side effects, including diarrhea, elevated alanine aminotransferase (ALT) levels, hypertriglyceridemia, dry mouth, and oral ulcers. URAT1 inhibitors are among these treatments. This study aims to investigate whether the traditional treatment referred to as ’basti’ has an inhibitory effect on the URAT1 protein, which is released as a result of metabolic changes associated with gout. |