| CTRI Number |
CTRI/2023/07/055850 [Registered on: 28/07/2023] Trial Registered Prospectively |
| Last Modified On: |
15/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Vaitarana Basti and Shatpushpadi lepa in Arthritis (Amavata) |
|
Scientific Title of Study
|
Comparative clinical evaluation of Vaitarana Basti and Shatpushpadi lepa in Amavata (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 KK Sharma |
| Designation |
Professor & H.O.D |
| Affiliation |
Rishikul Campus Haridwar |
| Address |
Department of Panchkarma, Rishikul Campus, UAU, Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9758264164 |
| Fax |
|
| Email |
kripayanam@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr KK Sharma |
| Designation |
Professor & H.O.D |
| Affiliation |
Rishikul Campus Haridwar |
| Address |
Department of Panchkarma, Rishikul Campus, UAU, Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9758264164 |
| Fax |
|
| Email |
kripayanam@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Sanjna Sharma |
| Designation |
PG Scholar |
| Affiliation |
Rishikul Campus Haridwar |
| Address |
Department of Panchkarma, Rishikul Campus, UAU, Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
8557904727 |
| Fax |
|
| Email |
superbsanjna@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rishikul Campus, Haridwar , Uttarakhand Ayurved University |
|
|
Primary Sponsor
|
| Name |
Rishikul Campus |
| Address |
Department of Panchkarma Rishikul Campus Haridwar |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrSanjna Sharma |
Rishikul campus, UAU, Haridwar |
Department of Panchakarma, OPD no. 20 (249401)
Hardwar
UTTARANCHAL |
8557904727
superbsanjna@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M059||Rheumatoid arthritis with rheumatoid factor, unspecified. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | lepa, लेप | (Procedure Reference: yogratnakara amavata chikitsa adhikara, Procedure details: Poorva karma: Firstly Koshtha Shodhana with Eranda Sneha will be done on previous day.
Then next day washing affected joint with lukewarm water.
Pradhan karma: Application of Lepa on the affected joint.
Paschat karma: Removal of Lepa after it get dried & washing it with lukewarm water.
)
(1) Medicine Name: Shatpushpadi , Reference: Yogratnakar amavata chikitsa adhikar, Route: Topical, Dosage Form: Lepa Churna, Dose: 40(g), Frequency: od, Duration: 21 Days | | 2 | Intervention Arm | Procedure | - | vaitaraNa-bastiH, वैतरण-बसà¥à¤¤à¤¿à¤ƒ | (Procedure Reference: chakradutta niruhadhikara, Procedure details: Poorva karma: Kostha Shodhana with Eranda Sneha on next day Sthanika Abhyanga and Swedana will be done. Pradhana karma: Vaitarana Basti will be given in left lateral position. Paschat karma: Gluteal region will be strike with palms & Patient will be advised to follow Pathya Ahara-Vhihara. ))
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients having sign and symptoms of Amavata (Rheumatoid arthritis).
2. Patients of age between 20 years to 50 years will be included.
3. Patients with less than 5 years of chronicity.
4. Patients able to participate in study and ready to follow the instruction. |
|
| ExclusionCriteria |
| Details |
1. Patients with joint deformity.
2.Uncontrolled diabetes mellitus, Hypertension & life threatening disease.
3. Patients having dermatomyositis, scleroderma, acute rheumatic fever , gouty arthritis.
4. Patients having Skin allergy and hypersensitivity.
5. Pregnant and lactating women
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Complete remission: 100%
Marked improvement: 75%
Moderate improvement: 51%-75%
Mild improvement: 26%-50%
No improvement: 0-25%
|
0th, 30th, 60th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Exacerbation in sign & symptoms |
60 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
N/A |
|
Date of First Enrollment (India)
|
30/07/2023 |
| 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="0"
Months="11"
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
|
Amavata is progressive sporadic disorder found in general population with complaints of doing routine work due to dysfunction of joints. Amavata was first expained in Madhav Nidana. Clinical presentation of Pravriddha Amavata closely resembles with Rheumatoid arthritis which is chronic multisystem disease of unknown cause. The characteristic feature of RA are persistent inflammatory synovitis, usually involving peripheral joints in symmetrical distributions. Now a days rheumatoid arthritis is more common and distressing among all joints problems. The prevalence of rheumatoid arthritis in worldwide is 0.8% and in India it is 0.7%. Patients of amavata presents with complaints of angamarda, aruchi, trishna, gaurava along with complaints of sandhishoola, sandigraha and sandhisotha. Symptoms of RA includes pain and swelling in affected joints and morning stifness. The therapy chosen for this study is Vaitarana basti in comparison with Shatpushpadi lepa. Vaitarana basti is mentioned in Chakradutta and is said to having shoola, anaha and amavatahara properties. Shatpushpadi lepa is mentioned in Yogratanakara. Lepa contols doshas at localized level and offers instant relief as skin provides large surface area and is easy to use. |