| CTRI Number |
CTRI/2021/07/035108 [Registered on: 26/07/2021] Trial Registered Prospectively |
| Last Modified On: |
15/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
" Study of Twacha and role of Ayurvedic preparation on hyperpigmentation." |
|
Scientific Title of Study
|
comprehensive study of Twaka Sharir w.s.r. to Vyanga and its management through Varnya Mahakashaya and Arjuna Twaka Lepa.†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
kumari neelam |
| Designation |
MD Scholar |
| Affiliation |
National Institute of Ayurveda,Jaipur |
| Address |
Room No.-116
Sharir Rachana Department, National institute of Ayurveda, Jaipur
Rajasthana
302002 (India)
Jaipur
RAJASTHAN
302002
India |
| Phone |
9983322772 |
| Fax |
|
| Email |
rainilam98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunil Kumar |
| Designation |
MD Phd (Ayu) professor(HOD Sharir Rachana department |
| Affiliation |
National Institute of Ayurveda,Jaipur |
| Address |
Room No.-106
Sharir Rachana Department, National institute of Ayurveda, Jaipur
Rajasthana
302002 (India)
Jaipur
RAJASTHAN
302002
India |
| Phone |
9414077592 |
| Fax |
|
| Email |
drsunilkumarbhu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kumari neelam |
| Designation |
MD scholar |
| Affiliation |
National Institute of Ayurveda,Jaipur |
| Address |
Room No.-116
Sharir Rachana Department, National institute of Ayurveda, Jaipur
Rajasthana
302002 (India)
Jaipur
RAJASTHAN
302202
India |
| Phone |
9983322772 |
| Fax |
|
| Email |
rainilam98@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Instutute of Ayurveda,Jaipur |
|
|
Primary Sponsor
|
| Name |
National Institute of AyurvedaJaipur |
| Address |
National Institute of Ayurveda,Jaipur Amer Road 302002 |
| 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 |
| kumari Neelam |
NIA Hospital OPD NO.3 Jaipur |
Room no.-116,Sharir Rachana deprtment ,National Institute of Ayurveda ,Amer road Jaipur,Rajasthana 302002
Jaipur
RAJASTHAN |
9983322772
rainilam98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Cmmittee,National Institute of Ayurveda Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: VaYaaMga, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
group A |
15 patient - Varnya Mahakshaya - 48 ml twice a day (orally) for 60 days |
| Comparator Agent |
Group B |
15 patient-Arjuna Twaka Lepa (local application ) for 60 day |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient with the classic signs and symptoms of Vyanga
2.Patients of either sex
3.Patients of age between 16-60years |
|
| ExclusionCriteria |
| Details |
Patient of hormonal diseases.
Incurable skin disease mentioned in Ayurveda Samhita.
Case of burn.
Any skin allergy.
Women those taking oral contraceptive pills therapy.
Malignance |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To access the efficacy of Varnya Mahakshaya and Arjuna Twaka Churna in management of Vyanga(melasma).
|
60 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| not applicable |
61 DAYS |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
02/08/2021 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
1. For instance, dermatologist Thomas b. Fitzpatrick classifies the types of skin on basis of presence of percentage of melanin. The classification of skin given by Acharya Sushruta is commonly perceived to be the seven layers of skin present in a person one below the other.
2. His study is undertaken to understand the concept of Twaka Sharir, analyses the basis of classification of Twaka and to clinically prove the efficacy of Mahakshaya Kwath (oral administration) and Arjuna Twaka Churna with Ksheer (milk) Lepa (local application) in Vyanga Vyadhi.
AIM & OBJECTIVES
Conceptual study of Twaka Sharir
To understand the basis of classification of Twacha.
To access the efficacy of Varnya Mahakshaya and Arjuna Twaka Churna in management of Vyanga(melasma).
Nullhypothesis ;-
There is no significant difference between the effect of Varnya Mahakashyam and Arjuna twaka lepa on vyanga.
|