| CTRI Number |
CTRI/2020/11/028990 [Registered on: 09/11/2020] Trial Registered Prospectively |
| Last Modified On: |
05/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative study to evaluate the efficacy of two Ayurvedic formulated Enemas in Rheumatoid Arthritis |
|
Scientific Title of Study
|
Comparative study to evaluate the efficacy of Kshara basti and Erandmooladi niruha basti in Amavata (Rheumatoid arthritis) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amit Tiwari |
| Designation |
PG Scholar |
| Affiliation |
Patanjali Ayurvigyan evam anusandhan Sansthan, Haridwar |
| Address |
OPD NO 4,Department of Panchkarma,
Patanjali Ayurveda Hospital, Haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9084798665 |
| Fax |
|
| Email |
amittiwari.tiwari5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivani Mahajan |
| Designation |
Associate Professor |
| Affiliation |
Patanjali Ayurvigyan evam anusandhan Sansthan, Haridwar |
| Address |
OPD NO 4,Department of Panchkarma,
Patanjali Ayurveda Hospital, Haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9760376767 |
| Fax |
|
| Email |
drshivani84@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivani Mahajan |
| Designation |
Associate Professor |
| Affiliation |
Patanjali Ayurvigyan evam anusandhan Sansthan, Haridwar |
| Address |
OPD NO 4,Department of Panchkarma,
Patanjali Ayurveda Hospital, Haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9760376767 |
| Fax |
|
| Email |
drshivani84@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Ayurveda Hospital Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar |
|
|
Primary Sponsor
|
| Name |
Patanjali Ayurveda College |
| Address |
Patanjali Ayurveda Hospital Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Amit Tiwari |
OPD no. 4 Dept of Panchkarma Patanjali Ayurveda Hospital Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Amit Tiwari |
Patanjali Ayurveda Hospital |
OPD no. 4 Dept of Panchkarma Patanjali Ayurveda Hospital Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar
Hardwar
UTTARANCHAL |
9084798665
amittiwari.tiwari5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PAC/IEC/2018-19/09 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M057||Rheumatoid arthritis with rheumatoid factor without organ or systems involvement, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Erand Mooladi Niruha Basti in Yog Basti schedule |
In this process, Erandamooladi Niruha Basti around 768 mL (Madhyam Matra) is given in Yoga Basti pattern and Anuvasana Basti around 100 mL of Murchita Tila Taila is given to the patient followed by Parihara Kala for 16 days from 9th day onwards. |
| Intervention |
Kshara Basti in Yog Basti schedule. |
In this process, Kshara Basti around 500 mL is given in Yoga Basti pattern and Anuvasana Basti around 70 mL of Murchita Tila Taila is given to the patient followed by Parihara Kala for 16 days from 9th day onwards. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with classical features of Amavata.
2. Patients fit for Basti Karma. |
|
| ExclusionCriteria |
| Details |
1. Age <20 and >60 years.
2. Complication including contractures nodule etc.
3. Having severe crippling deformity.
4. Patients with history of any direct or indirect trauma to joints.
5. Pregnancy & lactating mothers.
6. Patients who are unfit for Basti Karma.
7. Any major systemic disorder like CA, CRF, Liver Cirrhosis, CAD etc. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment will be based on:
1. Subjective parameters- Sandhi ruja( pain in joints),
Sandhi Shotha (joint swelling),
Stabdhata (stiffness),
Ushanata (Heat over the affected joints), Sparshasahyata (tenderness about the joints)
And
2. Objective parameters- RA-Factor, ESR, CRP, ASO, S.Uric Acid |
Before treatment and follow up of 8 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessment will be based on:
1. Subjective parameters- Sandhi ruja( pain in joints),
Sandhi Shotha (joint swelling),
Stabdhata (stiffness),
Ushanata (Heat over the affected joints), Sparshasahyata (tenderness about the joints)
And
2. Objective parameters- RA-Factor, ESR, CRP, ASO, S.Uric Acid |
After treatment completion |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
16/11/2020 |
| 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
|
No publication yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
As explained in samhitas, basti is the treatment for vataj disorders, so in view of that, we are using kshara basti in rheumatoid arthritis |