| CTRI Number |
CTRI/2026/01/100864 [Registered on: 12/01/2026] Trial Registered Prospectively |
| Last Modified On: |
12/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Panchakarma Procedure And Ayurvedic Medicine In The
Management of Amavata W.S.R To Rheumatoid Arthritis. |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY
OF AJMODADI VATAK WITH AND WITHOUT DWIPANCHMOOLADI
NIRUHA BASTI IN THE MANAGEMENT OF AMAVATA WITH SPECIAL
REFERENCE TO 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 Himani Bhardwaj |
| Designation |
PG SCHOLAR |
| Affiliation |
|
| Address |
Department Of Panchakarma, Dayanand Ayurvedic College,
Mahatma Hansraj Marg, Gurdev Nagar, Jalandhar (Punjab),
Pincode- 144008, India
Jalandhar
PUNJAB
144008
India |
| Phone |
8278710767 |
| Fax |
|
| Email |
thevedichealer01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neetika Nirmal |
| Designation |
Associate Professor |
| Affiliation |
|
| Address |
Department Of Panchakarma, Dayanand Ayurvedic College,
Mahatma Hansraj Marg, Gurdev Nagar, Jalandhar (Punjab),
Pincode- 144008, India
Jalandhar
PUNJAB
144008
India |
| Phone |
8219756483 |
| Fax |
|
| Email |
neetikanirmal1990@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Himani Bhardwaj |
| Designation |
PG SCHOLAR |
| Affiliation |
|
| Address |
Department Of Panchakarma, Dayanand Ayurvedic College,
Mahatma Hansraj Marg, Gurdev Nagar, Jalandhar (Punjab),
Pincode- 144008, India
Jalandhar
PUNJAB
144008
India |
| Phone |
8278710767 |
| Fax |
|
| Email |
thevedichealer01@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dayanand Ayurvedic College, Mahatma Hansraj Marg, Jalandhar (Punjab), Pin Code- 144008,
India |
|
|
Primary Sponsor
|
| Name |
Dayanand Ayurvedic College |
| Address |
Dayanand Ayurvedic College, Mahatma Hansraj Marg, Jalandhar
(Punjab), Pin Code- 144008, India |
| Type of Sponsor |
Private medical college |
|
|
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 Himani Bhardwaj |
Dayanand Ayurvedic College And Hospita |
Department Of Panchakarma, Dayanand Ayurvedic College, Mahatma Hansraj Marg, Jalandhar (Punjab), Pincode- 144008, India, Jalandhar, PUNJAB
Jalandhar
PUNJAB |
8278710767
thevedichealer01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DAC Institutional Ethical Committee |
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 | Comparator Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Charak Samhita Siddhi Sthan Ch.3, Procedure details: Poorva Karma: • It will involve Snehana of abdomen, back, thigh & legs followed by Nadi Sveda. Pradhana Karma: • Patient will be asked to lie down in the left lateral position with left leg straight and right leg flexed, his head should rest on his left flexed arm. • Sukhoshna Sneha will be applied in the anal region and on the Basti Netra. • Basti Netra will be introduced gradually & patient is asked to breath in. • Basti Dravya will be pushed into the rectum with constant pressure till a little quantity is remained in the Putaka (to prevent Vayu to enter into the Pakvashaya) • At last, Netra will be then withdrawn slowly. Paschat karma: • Patient will be asked to keep lying till the patient is able to hold Basti for better absorption of drug from anal region. • Patient will be asked to lie down with his face upward after getting the urge he will eliminate the faeces sitting on his heels. • After defecation patient will be asked to take a bath with warm water and have a light meal. Anuvasana Basti: • This will be done in the same way except in Poorva karma patient will be asked to have light meal prior to Basti Karma. • In Paschat Karma patient’s buttocks will be patted, lower abdomen will be massaged, legs will be raised for a while to increase the retention period. ))
(1) Medicine Name: Dwipanchamooladi Niruha Basti, Reference: Charak Sidhisthan 3/59–60, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 600(ml), Frequency: od, Duration: 6 Days(2) Medicine Name: Brihatsaindhavadi Taila, Reference: Bhaishajya Ratnawali 29/ 216–221 , Route: Rectal, Dosage Form: Taila, Dose: 50(ml), Frequency: od, Duration: 10 Days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ajmodadi Vatak, Reference: Chakradutt 25/52-56, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Ushanodaka), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects fulfilling the 2010 EULAR/ACR revised criteria of Amavata (Rheumatoid Arthritis).
2. Subjects fit for Basti.
3. Subjects aged between 30 to 60 years of either sex.
4. Subjects with controlled Hypertension & Diabetes.
5. Subjects willing to participate in study. |
|
| ExclusionCriteria |
| Details |
1.Subjects having Upadrava and Arista laxana
2.Amavata associated with severe complicated diseases like Diabetes mellitus, cardiac disease,
tuberculosis, AIDS.
3. Subjects with severe deformities, severe ankylosed joints, septic arthritis and gouty arthritis etc
4.Pregnant women & lactating women. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Following symptoms will be assessed for the reduction in their severity:
1. Sandhishoola (pain in joints)
2. Sandhishopha (swelling in joints)
3. Jadya (Stiffness over affected joint)
4. SparshaAsahtva (tenderness)
5. Vibhandha (constipation)
6. Angamarda (bodyache)
7. Alasya (lethargy)
8. Daha (burning sensation in body) |
On 0th, 16th, 30th, 40th Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Significant Improvement in the objective parameters.
1. RA Factor Quantitative
2. ESR
3. CRP
4. Anti - CCP |
On 0th and 40th day. |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
27/01/2026 |
| 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
|
The total of 60 patients will be selected who are between age
group of 30 to 60 years of either sex who are diagnosed with Amavata on the
basis of sign and symptoms. Patients will be divided into two groups (Trial
Group A and Trial Group B). Group A will be intervene with Dwipanchmooladi
Niruha Basti along with oral administration of Ajmodadi Vatak and Group B will
be intervene with oral administration of Ajmodadi Vatak and conduct a clinical
study - To evaluate the efficacy of Ajmodadi Vatak in the management of
Amavata w.s.r to Rheumatoid Arthritis. • To evaluate the combined efficacy of
Dwipanchmooladi Niruha Basti with oral administration of Ajmodadi Vatak in the
management of Amavata. • To compare the efficacy of Ajmodadi Vatak with and
without Dwipanchmooladi Niruha Basti in the management of Amavata w.s.r. to
Rheumatoid Arthritis
|