| CTRI Number |
CTRI/2025/01/079681 [Registered on: 28/01/2025] Trial Registered Prospectively |
| Last Modified On: |
24/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Management of Aamvata through Ayurveda |
|
Scientific Title of Study
|
A CLINICAL STUDY TO EVALUATE THE ANALGESIC EFFICACY OF SHOOLPRASHAMANAM MAHAKASHAYAM GHAN VATI ALONG WITH DASHMOOLA KWATH IN PAIN [SHOOL] MANAGEMENT OF 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 urvashi chandrol |
| Designation |
MD scholar |
| Affiliation |
pt khushilal sharma gov Ayurvedic college bhopal mp |
| Address |
PG department of kayachikitsa Pt Khushilal Sharma Government (Autonomous) Ayurveda College and Institute Bhopal
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
09893994991 |
| Fax |
|
| Email |
chandrolurvashi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swati nagpal |
| Designation |
Reader |
| Affiliation |
pt khushilal sharma gov. Ayurvedic college, bhopal |
| Address |
PG department of kayachikitsa Pt Khushilal Sharma Government (Autonomous) Ayurveda College and Institute Bhopal
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9406970945 |
| Fax |
|
| Email |
nagpalswati460@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr urvashi chandrol |
| Designation |
MD scholar |
| Affiliation |
pt khushilal sharma gov. Ayurvedic college, bhopal |
| Address |
PG department of kayachikitsa Pt Khushilal Sharma Government (Autonomous) Ayurveda College and Institute Bhopal
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
09893994991 |
| Fax |
|
| Email |
chandrolurvashi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt khushilal sharma Government Autonomous colllege and institue, bhopal (m.p.) incidence 462003,India |
|
|
Primary Sponsor
|
| Name |
Pt khushilal sharma Government Autonomous colllege and institue bhopal mp |
| Address |
PG Department of Kayachikitsa Pt khushilal sharma Government Autonomous colllege and institue, bhopal (m.p.) ,pincode 462003,India |
| Type of Sponsor |
Government funding agency |
|
|
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 urvashi chandrol |
pt khushilal sharma government Ayurvedic hospital bhopal mp |
Room No. 221 PG department of kayachikitsa Pt khushilal sharma Government Autonomous colllege and institue, bhopal (m.p.)
Bhopal
MADHYA PRADESH |
9893994991
chandrolurvashi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics CommitteePt khushilal sharma Government Autonomous colllege and institue, bhopal (m.p.) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D805||Immunodeficiency with increased immunoglobulin M [IgM]. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: shoolprashmanam mahakashayam ghan vati, Reference: charak sutra 4, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: -Dashmoola kwath), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Diclofenac potassium | Diclofenac potassium as directed by modern physician |
|
|
|
Inclusion Criteria
|
| Age From |
26.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patient fulfilling the American college of Rheumatology revised criteria of RA.
Sign and symptoms of Amavata which are mention in our classics.
Patients willing and able to participate in the study and give written consent form |
|
| ExclusionCriteria |
| Details |
patients below 26 year and above 55 years Patients who develop secondary complications of R.A. e.g. Pleuro-pericardial disease, severely damaged joint with bed ridden patients and severe joint and crippling deformity .
Patient having any other serious illness e.g. Hepatic/renal failure, severe GERD.
Patients with diagnosed other arthritis like Gouty arthritis, tuberculosis or psoriatic arthritis etc.
Immunocompromised patient, cancer, AIDS, heart disease, polycystic kidney disease.
Pt. who are not willing to give consent |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
It is expected that at the end of the study, we would be able to demonstrate and explain the efficacy of Shoolprashamanam mahakashayam ghan vati along with Dashmoola kwath in the pain management of Amavat (RA).
|
12 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
It is expected that at the end of the study, we would be able to manage pain intensity of Aamvata with Shoolprashmanam Mahakashyam ghan vati along with Dashmool kwath
|
12 months |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/02/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
It is expected that at the end of the study we would be able to demonstrate and explain the efficacy of shoolprashamanam mahakashayam ghan vati along with Dashmoola kwath in the management of Amavata( rheumatois arthritis) |