| CTRI Number |
CTRI/2024/11/077317 [Registered on: 25/11/2024] Trial Registered Prospectively |
| Last Modified On: |
20/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the efficacy of Arthocan J100 Lep Powder in patients with Rheumatoid Arthritis(Aamvata) |
|
Scientific Title of Study
|
A Pilot Exploratory Clinical Study To Evaluate the efficacy of local application of Arthocan-J100 Lep Powder in Rheumatoid Arthritis (Aamvata) |
| 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 Pranesh P Gaikwad |
| Designation |
M.D. Panchakarma (Associate Professor) |
| Affiliation |
Dr. D.Y.Patil College of Ayurved and Research Centre, Pimpri Pune-18 |
| Address |
OPD No.9, Department of Panchakarma, Dr.D.Y.Patil College of Ayurveda and Research Centre, Sant Tukaram Nagar,Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8668259365 |
| Fax |
|
| Email |
pranesh.gaikwad@dpu.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pranesh P Gaikwad |
| Designation |
M.D. Panchakarma (Associate Professor) |
| Affiliation |
Dr. D.Y.Patil College of Ayurved and Research Centre, Pimpri Pune-18 |
| Address |
Panchakarma Department, OPD No.9, Dr.D.Y.Patil College of Ayurveda and Research Centre, Sant Tukaram Nagar,Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8668259365 |
| Fax |
|
| Email |
pranesh.gaikwad@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pranesh P Gaikwad |
| Designation |
M.D. Panchakarma (Associate Professor) |
| Affiliation |
Dr. D.Y.Patil College of Ayurved and Research Centre, Pimpri Pune-18 |
| Address |
Panchakarma Department, OPD No.9, Dr.D.Y.Patil College of Ayurveda and Research Centre, Sant Tukaram Nagar,Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8668259365 |
| Fax |
|
| Email |
pranesh.gaikwad@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
| Dr.D.Y.Patil College of Ayurved and Research Centre, Pimpri,Pune-18 |
|
|
Primary Sponsor
|
| Name |
Sudhatatva Pharmacy |
| Address |
Dr.D.Y.Patil College of Ayurveda and Research Centre, Sant Tukaram Nagar,Pimpri, Pune, Maharashtra 411018 |
| 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 Pranesh P Gaikwad |
Dr.D.Y.Patil College of Ayurveda and Research Centre, Pimpri,Pune |
Panchakarma department,OPD No
9,Dr.D.Y.Patil College of Ayurveda and Research Centre, Pimpri,Pune,Maharashtra-411018
Pune
MAHARASHTRA |
8668259365
pranesh.gaikwad@dpu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. D.Y.PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE INSTITUTIONAL ETHICS COMMITTEE, PIMPRI PUNE |
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. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Arthocan J100 Lepa Powder, Reference: NA, Route: Topical, Dosage Form: Lepa Churna, Dose: 20(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: 20gm of Arthocan J100 Lepa Powder mixed with adequate luke warm water, applied at affected joint,once a day |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having Inflammation of joints (Sandhi shotha)
2.Joint pain (Sandhi shool)
3.Restriction of joint movements (Sandhigraha)
4.Tenderness (Sparsha asahatva)
|
|
| ExclusionCriteria |
| Details |
1.Known case of Uncontrolled Diabetes Mellitus.
2.Known case of Vatarakta and Sandhigata vata.
3.Known case of Ankylosing Spondylosis
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary Outcome-Reduction in Sandhi shotha (inflammation of joint) by using the measuring tape before and after treatment with Local Application ArthoCan-J100 Lep Powder. |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary Outcome- Reduction in Sandhi shool (Pain in joints) using the VAS scale before and after treatment with Local Application ArthoCan-J100 Lep Powder. |
14 days |
|
|
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 |
|
Date of First Enrollment (India)
|
02/12/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 a Pilot Explanatory Clinical Study to evaluate the efficacy of local application of Arthocan J100 lep Powder in patients with Rheumatoid Arthritis(Amavata) Study design is a single arm clinical study.Total 30 patients will be enrolled.Assessment of patients on 1st and 14th day.Study duration will be 6 months
|