| CTRI Number |
CTRI/2024/07/071654 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
31/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Jalaukavcharana] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect Of Leech Therapy And Varnya Mahakashaya Churna In The Management Of Melasma |
|
Scientific Title of Study
|
A Comparative Clinical Study Of Jalaukavcharana And Jalaukavacharana Along With Varnya Mahakashaya Churna In The Management Of Vyanga Wsr To Melasma |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sana Kausar Sindhi |
| Designation |
Pg Scholar |
| Affiliation |
Madan Mohan Malviya Government Ayurved College Udaipur |
| Address |
PG Scholar
Shalya Tantra Department
Madan Mohan Malviya Government Ayurved College Ambamata Udaipur Rajasthan
PG Scholar
Shalya Tantra Department
Madan Mohan Malviya Government Ayurved College Ambamata Udaipur Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
7976466520 |
| Fax |
|
| Email |
sanakausar543@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Namo Narayan Meena |
| Designation |
Associate Professor |
| Affiliation |
MMM Government Ayurved College Udaipur Rajsthan |
| Address |
Departrment Of Shalya Tantra MMM Government Ayurved college Ambamata Udaipur Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
9928871125 |
| Fax |
|
| Email |
drnamorajat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Namo Narayan Meena |
| Designation |
Associate Professor |
| Affiliation |
MMM Government Ayurved College Udaipur Rajsthan |
| Address |
Department Of Shalya Tantra MMM Government Ayurved college Ambamata Udaipur Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
9928871125 |
| Fax |
|
| Email |
drnamorajat@gmail.com |
|
|
Source of Monetary or Material Support
|
| MMM Government Ayurved college Ambamata Udaipur Rajasthan 310031 |
|
|
Primary Sponsor
|
| Name |
MMM Government Ayurved College Udaipur Rajsthan |
| Address |
MMM Government Ayurved college Ambamata Udaipur Rajasthan India 313001 |
| Type of Sponsor |
Government medical college |
|
|
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 Sana Kausar Sindhi |
MMM Government Ayurved College And Hospital Udaipur Rajasthan |
Opd 1 Shalyatantra Department MMM Government Ayurved college Ambamata Udaipur Rajasthan 313001
Udaipur
RAJASTHAN |
7976466520
sanakausar543@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee MMM Government Ayurved College Udaipur Rajasthan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L818||Other specified disorders of pigmentation. Ayurveda Condition: VYANGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | jalaukAvacaraNam, जलौकावचरणमॠ| (Procedure Reference: Sushrut Samhita, Procedure details: Jalaukavacharana Once In A Week For 4 Weeks)
| | 2 | Intervention Arm | Procedure | - | jalaukAvacaraNam, जलौकावचरणमॠ| (Procedure Reference: Sushrut Samhita, Procedure details: Jalaukavacharana Once in A Week For 4 Week)
(1) Medicine Name: Varnyamahakashaya Churna, Reference: Charak Samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Duration: 04 Weeks |
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients with classical sign and symptoms of vyanga roga (melasma) Patients from the age group of 12 to 50 years of either sex,religion, occupation
Patients having upto 6 patches on the face
Those ready to give written informed consent.
Jalaukavacharana yogya patients as per classics.
|
|
| ExclusionCriteria |
| Details |
Hyperpigmentation since birth.
Patients having skin diseases like - psoriasis, leprosy,acne vulgaris,eczema and leukoderma.
Melasma due to leucorrhea,tubercular therapy or malignant cases.
Patients having endocrinal or systemic disease like Addison disease,cushing syndrome etc and
other deteriorating conditions of any illness.
Uncontrolled diabetes mellitus,hypertension, HIV, Hepatitis,immune deficiency syndrome.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Masi Score Number Of Patches On Face |
28 Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number Of Patches On Face |
28 Day 60 Day |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
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 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
|
This study is a comparartive clinical study of
jalaukavacharna and varnya mahakashaya churn a in the management of the
vyanga w.s.r. t0 melasma.there will be 2 group in the study ,in group a
randomly selected and clinically diagnosed 20 patient of vyanga
(melasma) .group a will be given intervention by jalaukavacharana
,and 20 patientof group b randomly selected and clinicaly
ddiagnose will be apply jalaukavacharna alond with varnya
mahakashaya churna.trial will be conducted for a period of 1 month .follow up
of the case will be done after completion of 2 months course on the basis
of primary and secondary outcomes.
The data will be analyzed scientifically and
statiscally.
|