| CTRI Number |
CTRI/2024/10/075256 [Registered on: 15/10/2024] Trial Registered Prospectively |
| Last Modified On: |
14/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To see the effect of local application of Arthocan-C25 tail in Rheaumatoid Arthritis |
|
Scientific Title of Study
|
A Pilot Exploratory Clinical Study To Evaluate The Efficacy of local Application of Arthocan-C25 Tail 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 Vaishali Chaudhari |
| Designation |
MD PANCHKARMA (Professor of panchkarma department) |
| Affiliation |
Dr D Y Patil College Of Ayurved And Research Centre |
| Address |
Opd No 9 Panchakarma Department Dr D Y Patil College Of
Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune
Maharastra 411018
Pune
MAHARASHTRA
411018
India
Pune
MAHARASHTRA
411018
India |
| Phone |
9822964710 |
| Fax |
|
| Email |
vaishali.chaudhari@dpu.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vaishali Chaudhari |
| Designation |
MD PANCHKARMA (Professor of panchkarma department) |
| Affiliation |
Dr D Y Patil College Of Ayurved And Research Centre |
| Address |
Opd No 9 Panchakarma Department Dr D Y Patil College Of
Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune
Maharastra 411018
Pune
MAHARASHTRA
411018
India
MAHARASHTRA
411018
India |
| Phone |
9822964710 |
| Fax |
|
| Email |
vaishali.chaudhari@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaishali Chaudhari |
| Designation |
MD PANCHKARMA (Professor of panchkarma department) |
| Affiliation |
Dr D Y Patil College Of Ayurved And Research Centre |
| Address |
Opd No 9 Panchakarma Department Dr D Y Patil College Of
Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune
Maharastra 411018
Pune
MAHARASHTRA
411018
India
MAHARASHTRA
411018
India |
| Phone |
9822964710 |
| Fax |
|
| Email |
vaishali.chaudhari@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
| Dr D Y Patil College Of Ayurved And Research Centre Pimpri Pune Maharashtra India 411018 |
|
|
Primary Sponsor
|
| Name |
SUDHATATVA Pharmacy |
| Address |
Dr. D.Y. Patil College of Ayurved and Research Center, Pimpri, 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 Vaishali R Chaudhari |
Dr D Y Patil College Of Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune |
Opd No 9 Panchakarma Department Dr D Y Patil College Of
Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune
Maharastra 411018
Pune
MAHARASHTRA
411018
India
Pune
MAHARASHTRA |
9822964710
vaishali.chaudhari@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 Reasearch Centre Institutional Ethics Committee Pimpri Pune-18 |
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 | Procedure | - | aBya~ggaH, अà¤à¥à¤¯à¤‚ग | (Procedure Reference: charak samhita, Procedure details: Phase 1: Head and Neck (5-7 minutes)
1. Apply oil to the scalp, massaging in circular motions with fingertips.
2. Massage the face, focusing on pressure points (e.g., temples, forehead).
3. Gently massage the neck, using upward strokes.
Phase 2: Arms and Hands (10-12 minutes)
1. Apply oil to arms, using long strokes from shoulder to wrist.
2. Massage shoulders, elbows, and wrists.
3. Focus on hands, massaging fingers, palms, and wrists.
Phase 3: Chest and Abdomen (10-12 minutes)
1. Apply oil to chest, using circular motions.
2. Massage abdomen, using gentle, clockwise strokes.
3. Focus on the solar plexus area.
Phase 4: Back and Spine (10-12 minutes)
1. Apply oil to back, using long strokes from neck to lower back.
2. Massage spine, using gentle pressure.
3. Focus on shoulder blades and lower back.
Phase 5: Legs and Feet (10-12 minutes)
1. Apply oil to legs, using long strokes from thighs to ankles.
2. Massage knees, calves, and ankles.
3. Focus on feet, massaging toes, soles, and heels.
Phase 6: Final Relaxation (5-7 minutes)
1. Apply gentle, soothing strokes to entire body.
2. Encourage relaxation and deep breathing.
Post-Abhyanga:
1. Leave oil on body for 15-30 minutes to allow absorption.
2. Take a warm bath or shower.
3. Relax and avoid strenuous activities.
Phase 6: Final Relaxation (5-7 minutes)
1. Apply gentle, soothing strokes to entire body.
2. Encourage relaxation and deep breathing.
Post-Abhyanga:
1. Leave oil on body for 15-30 minutes to allow absorption.
2. Take a warm bath or shower.
3. Relax and avoid strenuous activities.
)
(1) Medicine Name: Arthocan C25 tail, Reference: ayurvedic proprietary medicine, Route: Topical, Dosage Form: Taila, Dose: 30(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having inflammation of joint [Sandhi shoth]
1.Joint pain[sandhishool]
2.Restriction of joint movements [Sandhigraha]
3.Tenderness [Sparsha asahatva]
|
|
| ExclusionCriteria |
| Details |
1)Individuals with known case of uncontrolled diabetes mellitus.
2)Known case of vatarakta and Sandhigat 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 |
Reduction in inflammation of joint (Sandhishotha) using measuring tape before and after treatment of local application Arthocan -C25 oil.
|
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in Joint Pain (Sandhishoola) using the VAS scale before and after treatment of Local application of Arthocan- C25 oil.
|
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)
|
31/10/2024 |
| 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) |
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 A Pilot Exploratory Clinical Study To Evaluate The Efficacy of local
Application of Arthocan-C25 Tail in Rheumatoid Arthritis (Aamvata)
Study design is a single arm cilinical study
Total 30 patient will be enrolled
Assesment of patients on 1 st and 7 th day
total duration of study will be 12 months |