| CTRI Number |
CTRI/2024/01/061535 [Registered on: 16/01/2024] Trial Registered Prospectively |
| Last Modified On: |
10/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Praval bhasma, Lakshadi guggulu and local application of Dashang Lepa with pinda tail on knee joint pain in Hemophilia patients |
|
Scientific Title of Study
|
Clinical study to evaluate the efficacy of oral administration of Praval bhasma, Lakshadi guggulu and local application of Dashang Lepa with pinda tail on knee joints having arthritic changes in Hemophilia patients |
| 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 Arun Kumar |
| Designation |
Post Doctoral fellow |
| Affiliation |
Central Council for Research in Ayurvedic Sciences (CCRAS) |
| Address |
Preventive Cardiology Room,IPD,BLOCK-B,Central Ayurveda Research Institute
Dhanwantari Bhawan, Road No. 66 Punjabi Bagh
North West DELHI 110026 India |
| Phone |
7011891194 |
| Fax |
|
| Email |
akr4104@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Seema Jain |
| Designation |
Research Officer |
| Affiliation |
Central Ayurveda Research Institute |
| Address |
Preventive Cardiology Room,IPD,BLOCK-B,Central Ayurveda Research Institute
Dhanwantari Bhawan, Road No. 66 Punjabi Bagh
North West DELHI 110026 India |
| Phone |
8851677673 |
| Fax |
|
| Email |
dr_seema_jain@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Arun Kumar |
| Designation |
Post Doctoral fellow |
| Affiliation |
Central Ayurveda Research Institute |
| Address |
Preventive Cardiology Room,IPD,BLOCK-B,Central Ayurveda Research Institute
Dhanwantari Bhawan, Road No. 66 Punjabi Bagh
North West DELHI 110026 India |
| Phone |
7011891194 |
| Fax |
|
| Email |
akr4104@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Ayurvedic Sciences(CCRAS) |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Ayurvedic Sciences |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Avum Homeopathy Anusandhan Bhavan
No.61-65, Institutional Area, Opp. D Block, Janakpuri,
New Delhi - 110058 ( India )
|
| 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 |
| Dr Arun Kumar |
Central Ayurveda Research Institute |
Preventive Cardiology Room,IPD,BLOCK-B,Central Ayurveda Research Institute
Dhanwantari Bhawan, Road No. 66 Punjabi Bagh North West DELHI |
7011891194
akr4104@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Insitutional Ethical Committee CARI New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M250||Hemarthrosis. Ayurveda Condition: RAKTAPITTA-UPADRAVAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Lakshadi guggulu, Reference: bhaisajya ratnavali ,bhagnarogadhikar 49-13,14, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -luke warm water), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Praval Bhasma, Reference: Ayurvedic Pharmacopoeia of India, Part – 1, Second edition, page -613, Route: Oral, Dosage Form: Bhasma, Dose: 200(mg), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: luke warm milk), Additional Information: - | | 3 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: Sharangdhar samhita uttarkhand 11 chapter verse 1, Procedure details: 15 -30 gm of Dashang lepa mixed with luke warm pinda tail is gently appllied locally with 4-5mm thickened layer on affected knee joint once a day for 2 hours) (1) Medicine Name: Dashang lepa, Reference: bhaisajya ratnavali visarpa rogadhikar 16, Route: Topical, Dosage Form: Lepa Churna, Dose: 30(g), Frequency: od, Duration: 30 Days |
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Male |
| Details |
1. Stage 2 or 3 or 4 arthritic changes present in knee joint.
2. Pre diagnosed patient suffering from moderate to severe Hemophilia A or B from factor assay 8 or 9 or having valid registered id card from Hemophilia society or any government hospital showing factor percentage.
|
|
| ExclusionCriteria |
| Details |
1. Patient having Mild Hemophilia
2. Hemophilic patients whose Knee joints are not affected
3. Having stage 1 arthritic changes
4. Undergone knee replacement surgery
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in pain by V.A.S score of Hemophilia patients having arthritic changes in knee joint. |
Day 1
Day 30
Day 45 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-Improvement in Range of Motion ≥15 degree in affected knee joint by goniometer.
-Reduction in thickness of synovitis ≥1mm in affected knee joint by USG.
-Mild changes in x-ray of affected knee joint.
-Improvement in quality of life in Hemophilia patients.
|
Day 1
Day 30
Day 45 |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
20/01/2024 |
| 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="2" Months="0" 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
|
Hemophilia is the most common severe hereditary hemorrhagic disorder. Both Hemophilia A and B result from factor VIII and factor IX protein deficiency or dysfunction, respectively, and is characterized by prolonged and excessive bleeding after minor trauma or sometimes even spontaneously. There is Hemophilia C as well, which occurs due to deficiency of clotting factor XI but is rare. Recurrent joint bleeding (hemarthrosis) is the most frequent clinical manifestation of severe Hemophilia. Unless appropriately managed, even subclinical hemarthrosis can lead to the development of hemophilic arthropathy, a disabling condition characterized by joint remodeling, chronic pain, and a reduced quality of life, and eventually requires joint replacement. Given the lack of specific treatments to reduce bloodâ€induced synovitis, the prevention of bleeding is pivotal to the maintenance of joint health. Ayurveda has a great potential in dealing with the hemophilic arthropathy of joint caused by repeated hemarthrosis, but due to lack of awareness, study and researches, hemophilic patients are unable to take the treatment with the trust. My study will allow the hemophilic patients to use the Ayurvedic treatment with a trust to improve their quality of life, having less pain and improved confidence in them in this rare disorder. |