| CTRI Number |
CTRI/2022/11/047364 [Registered on: 16/11/2022] Trial Registered Prospectively |
| Last Modified On: |
11/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of Hemophilia according to Ayurveda |
|
Scientific Title of Study
|
Hemophilia as an Anukta Vyadhi-A discriptive study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrPallavi Abhijit Gune |
| Designation |
Associate professor |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
Rognidan department Yashwant ayurved college and P G training and research center Kodoli
Rognidan department Pune
Pune
MAHARASHTRA
416114
India |
| Phone |
7020269330 |
| Fax |
|
| Email |
drpallavigune@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjiri Deshpande |
| Designation |
Associate professor |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
Rognidan department Tilak ayurved mahavidyalaya Pune
Rognidan department Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
7020269330 |
| Fax |
|
| Email |
drmanjirideshpande24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrPallavi Abhijit Gune |
| Designation |
Associate professor |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
Rognidan department Yashwant ayurved college and P G training and research center Kodoli
Rognidan department Pune
Pune
MAHARASHTRA
416002
India |
| Phone |
7020269330 |
| Fax |
|
| Email |
drpallavigune@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hemophilia society Dabholkar charitable trusts hospital Dabholkar corner 328/E new shahupuri Kolhapur |
|
|
Primary Sponsor
|
| Name |
self |
| Address |
Dabholkar hospital Dabholkar crner Kolhapur |
| 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 pallavi abhijit gune |
Dabholkar charitable trusts hospital |
Dabholkar hospital Hemophilia society office 3 rd floor Dabholkar corner station road kolhapur 416002
Kolhapur
MAHARASHTRA |
7020269330
drpallavigune@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D66||Hereditary factor VIII deficiency, (2) ICD-10 Condition: D67||Hereditary factor IX deficiency, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Month(s) |
| Age To |
15.00 Year(s) |
| Gender |
Male |
| Details |
Diagnosed patients of Hemophilia A and Hemophilia B |
|
| ExclusionCriteria |
| Details |
Patients with history of any other congenital disorder
Patients with bleeding disorder other than Hemophilia
Patients with diseases like cardiac disorders malignancies etc |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| affected systems due to hemophilia according to Ayurveda and its signs ans symptoms |
two years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study Beejadushtijanya vikaraTo study similarities between Raktapitta and Hemophilia
To study the various aspects of Dosha vikruti dushya vikruti Nidanpanchak of Hemophilia according to Ayurvedic and modern science |
two years |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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
|
N/A |
|
Date of First Enrollment (India)
|
17/11/2022 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To study Nidanpanchak and various vikruti of Dosha Dushya in Hemophilia according to Ayurvedic perspective.To study the Hemophilia as an Anukta vyadhi and Beejadushtijanya Vikara To study similarities between Raktapitta and Hemophilia |