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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M250||Hemarthrosis. Ayurveda Condition: RAKTAPITTA-UPADRAVAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(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: -
2Intervention ArmDrugClassical(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: -
3Intervention ArmProcedure-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 blood‐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.

 
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