| CTRI Number |
CTRI/2026/01/101887 [Registered on: 23/01/2026] Trial Registered Prospectively |
| Last Modified On: |
22/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [Assessment based on Inflammatory markers] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical Comparison of Modified Erandamoola Niruha Basti and Kshara Basti for reducing Inflammation in patients with Rheumatoid Arthritis |
|
Scientific Title of Study
|
A Comparative Clinical Study to Evaluate the Efficacy of Modified Erandamoola Niruha Basti and Kshara Basti on Inflammatory markers in Rheumatoid 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 Sushma S Bhat |
| Designation |
PG Scholar |
| Affiliation |
SDM Institute of Ayurveda and Hospital, Anchepalya |
| Address |
SDM Institute of Ayurveda and Hospital, Anchepalya, Bengaluru- 560074
Bangalore
KARNATAKA
560074
India |
| Phone |
9164893754 |
| Fax |
|
| Email |
sushma.bhat59@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arun B Jainer |
| Designation |
Professor |
| Affiliation |
SDM Institute of Ayurveda and Hospital, Anchepalya |
| Address |
Department of Panchakarma,
SDM Institute of Ayurveda and Hospital, Anchepalya, Bengaluru- 560074
Bangalore
KARNATAKA
560074
India |
| Phone |
9900940333 |
| Fax |
|
| Email |
draruns@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arun B Jainer |
| Designation |
Professor |
| Affiliation |
SDM Institute of Ayurveda and Hospital, Anchepalya |
| Address |
Department of Panchakarma,
SDM Institute of Ayurveda and Hospital, Anchepalya, Bengaluru- 560074
Bangalore
KARNATAKA
560074
India |
| Phone |
9900940333 |
| Fax |
|
| Email |
draruns@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM Institute of Ayurveda and Hospital, Anchepalya, Bangalore- 560074 |
|
|
Primary Sponsor
|
| Name |
Dr Sushma S Bhat |
| Address |
SDM Institute of Ayurveda and Hospital, Anchepalya, Bengaluru- 560074 |
| 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 Sushma S Bhat |
SDM Institute of Ayurveda and Hospital |
OPD 13
Department of Panchakarma
SDM Institute of Ayurveda and Hospital, Anchepalya, Bengaluru- 560074
Bangalore
KARNATAKA |
9164893754
sushma.bhat59@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee SDM Institute of Ayurveda and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M069||Rheumatoid arthritis, unspecified. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Charaka Samhita, Siddhi sthana, Procedure details: Patient is made to lie in left lateral position. Prepared basti dravya is inserted through rectal route. Advised to avoid Ashtamahavarjyakara bhava.)
| | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kshara basti ingredients, Reference: Chakradatta and Vangasena, Route: Rectal, Dosage Form: Kwatha/ Kashaya, Dose: 500(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 8 Days, anupAna/sahapAna: No, Additional Information: Anuvasana basti with Brihat saindhavadi taila 60ml, given after food in rectal route. | | 3 | Comparator Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Charaka Samhita, Siddhi sthana, Procedure details: Patient is made to lie in left lateral position.
Prepared basti dravya is inserted through rectal route.
Advised to avoid Ashtamahavarjyakara bhava.)
| | 4 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Modified Erandamoola niruha ingredients, Reference: NA, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 500(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 8 Days, anupAna/sahapAna: No, Additional Information:
Niruha basti dravya is prepared by mixing Madhu, Lavana, Eranda taila, Putoyavanyadi kalka, Erandamoola kashaya as per Basti samyojana vidhi.
Anuvasana basti with Brihat saindhavadi taila 60ml, given after food in rectal route. |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients presenting with one or more signs and symptoms of Rheumatoid Arthritis.
2) Patients irrespective of gender within the age group of 20 years to 60 years.
3) Patients with complaints of multiple joint pain less than or equal to 5 years.
4) Sero-positive and Sero-negative Rheumatoid Arthritis.
5) Freshly diagnosed patients of Rheumatoid Arthritis.
6) Patients who are Yogya for Basti.
7) Patients who are voluntarily willing to sign informed consent. |
|
| ExclusionCriteria |
| Details |
1) Congenital deformities of the joints.
2) Patients suffering from major illnesses like HIV, Tuberculosis, Syphilis, malignancy etc.
3) Patients having fracture and joint deformities.
4) Any major systemic illness which interferes with the line of treatment.
5) Pregnancy and Lactating women.
6) Anasthapya are excluded.
7) Patients on DMARD (Disease Modifying Anti Rheumatic Drugs) therapies. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment of change in the Inflammatory markers of Rheumatoid Arthritis mentioned under
Objective parameters. |
1st Assessment on 0th day (Before treatment).
2nd Assessment on 9th day (After treatment).
Follow up on 24th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improving the Quality of life related to Rheumatoid Arthritis. |
1st Assessment on 0th day (Before treatment).
2nd Assessment on 9th day (After treatment).
Follow up on 24th 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/ Phase 3 |
|
Date of First Enrollment (India)
|
02/02/2026 |
| 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 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
|
Pain is an unpleasant sensory and emotional experience in response to damage or injury. It hampers the day-to-day activities of the affected individual. One among such pain causing diseases is Rheumatoid Arthritis. Rheumatoid Arthritis is a common form of inflammatory arthritis, occurring throughout the world and in all ethnic groups. It is a chronic inflammatory disorder which affects many joints, including the major and minor joints of hands and feet. The prevalence of this disease in India differs from 0.5 to 3.8 % in women and from 0.15 to 1.35 % in men with a female-to-male ratio of 3:1 which suggests that females are affected three times more than that of males. To diagnose Rheumatoid Arthritis there are many subjective and objective parameters. Along with that, there are some investigations which are called as Inflammatory markers. Among them RA factor, CRP and ESR are very important markers for Rheumatoid Arthritis, and these tests provide the accuracy of inflammation and severity of the disease up to 90% which support the treatment protocol. Basti is an important Panchakarma in Ayurveda as it has been described by Acharya Charaka as Sarvam ‘Chikitsaamapi Bastimeke’ and ‘Chikitsaardhamiti bruvanti’. This statement says that Basti can be administered in almost all diseases. It’s sphere of action is Aapaada Mastaka (head to toe). Acharya Sushruta opines that Basti retains in Pakwashaya and dwells doshas from all over the body. Kshara Basti is explained as one such Basti which is beneficial in Amavata by Chakradatta. Eranda is explained to be the Gajakesari (best) in Amavata. It has an Agnideepana and Amapachana effect in the body, which breaks the samprapti (pathogenesis) of Amavata. Hence, in this study an attempt has been made to understand the variation in the Inflammatory markers for Rheumatoid Arthritis after Modified Erandamoola niruha basti and Kshara basti chikitsa. |