| CTRI Number |
CTRI/2023/10/058528 [Registered on: 11/10/2023] Trial Registered Prospectively |
| Last Modified On: |
10/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative Study of ayurveda treatment (bhrihati bhavit gunja lep )and prp (platelet rich plasma)he Therapy In Khalitya |
|
Scientific Title of Study
|
A Comparitive Clinical Study To Evaluate The Effect Of Pracchanakarma Followed By Brihati Bhavit Gunja Lepa And Platelet Rich Plasma (PRP) Therapy In Khalitya |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sudipta Kumar rath |
| Designation |
Associate Professor dravyagun |
| Affiliation |
National Institute of Ayurveda jaipur |
| Address |
Dept Saundarya ayurveda National institute of ayurveda Jorawar Singh Gate Jaipur raj
Jaipur
RAJASTHAN
302002
India |
| Phone |
9828376668 |
| Fax |
|
| Email |
Sudipt@nia.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Narendra singh |
| Designation |
Associate Professor dept shalaya |
| Affiliation |
National Institute of Ayurveda jaipur |
| Address |
Department of shalya National Institute of Ayurveda Jorawar Singh Gate Jaipur raj
Jaipur
RAJASTHAN
302002
India |
| Phone |
9549370912 |
| Fax |
|
| Email |
narinder.1973@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Punit Goswami |
| Designation |
MSc scholar |
| Affiliation |
National Institute of Ayurveda jaipur |
| Address |
Dept Saundarya ayurveda National institute of ayurveda Jorawar Singh Gate raj jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9887115683 |
| Fax |
|
| Email |
Parbrahm2013@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda, Deemed to be university, Jaipur |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda Deemed to be university |
| Address |
Dept Saundarya ayurveda National institute of ayurveda Deemed to be university Jorawar Singh Gate Jaipur Raj |
| 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 Punit Goswami |
National Institute of Ayurveda Deemed to be university Jaipur |
Opd no.19 National Institute of Ayurveda Deemed to be university Jorawar Singh Gate Jaipur
Jaipur
RAJASTHAN |
9887115683
Parbrahm2013@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee of national institute of ayurveda Deemed to be university |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:PCS||. Ayurveda Condition: KHALITYAM/KHALATI, (2) ICD-10 Condition:L00-L99||Diseases of the skin and subcutaneous tissue. Ayurveda Condition: KHALITYAM/KHALATI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: Lepa, Procedure details: Lepa is applied once a day)
(1) Medicine Name: Brihti bhavit gunja lepa, Reference: Bhaishjya ratnavalli, Route: Topical, Dosage Form: Lepa Churna, Dose: 0(g), Frequency: od, Duration: 3 Months | | 2 | Comparator Arm (Non Ayurveda) | | - | Plasma reach platelet | In prp procedure the blood from the patient is taken and centrifuge. Than the plasma is separated and injected in to the affected area of patient. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
As per diagnostic criteria of khalitya , pull test , hairfall count |
|
| ExclusionCriteria |
| Details |
Abnormal clotting time and bleeding time, patient with known history of endocrine disorders, patient with known history of systemic disease like TB etc., congenital ectodermal defects congenital disorders, khalitya due to burns or drug induced. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| According to SALT score & AA-IGA assessment scale |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Subjective symptoms criteria hair texture hair fall hair loss will be considered with before & after photos |
90 days |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
18/10/2023 |
| 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="3"
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
|
Need of study Due to limitations of modern medicine there is highest need to develop harmless , effective , painless , cost effective treatment.
MATERIAL AND METHODS Group A = brihatibhavit gunja lep is used after pracchan. Group B = platelets rich plasma therapy is given once in three weeks
|