| CTRI Number |
CTRI/2021/05/033443 [Registered on: 07/05/2021] Trial Registered Prospectively |
| Last Modified On: |
06/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Ingudi Paste and Jatiphala Paste in Vyanga (Melasma) |
|
Scientific Title of Study
|
A Comparative Randomized Clinical trial of Ingudi Lepa and Jatiphala Lepa in the management of Vyanga with special reference to Melasma |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhawani Singh Rathore |
| Designation |
PG scholar Dravyaguna dept. NIA jaipur |
| Affiliation |
National Institute of AyurvedaDeemed to be University jaipur Rajasthan |
| Address |
National Institute of Ayueveda Jaipur jorawer singh gate amer road jaipur rajasthan National Institute of Ayurveda jaipur Rajasthan Jaipur
RAJASTHAN 302002
India
nia jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9414229977 |
| Fax |
|
| Email |
bhawani.dr.rathore@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mita Kotecha |
| Designation |
Prof and HOD of Dravyaguna dept. NIA jaipur |
| Affiliation |
National Institute of Ayueveda Jaipur |
| Address |
National Institute of Ayueveda Jaipur jorawer singh gate amer road jaipur rajasthan National Institute of Ayurveda jaipur Rajasthan Jaipur
RAJASTHAN 302002
India
National Institute of Ayueveda Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9414078872 |
| Fax |
|
| Email |
mita@ayu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhawani Singh Rathore |
| Designation |
PG scholar Dravyaguna dept. NIA jaipur |
| Affiliation |
National Institute of Ayueveda Jaipur |
| Address |
National Institute of Ayueveda Jaipur jorawer singh gate amer road jaipur rajasthan National Institute of Ayurveda jaipur Rajasthan Jaipur
RAJASTHAN 302002
India
National Institute of Ayueveda Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9414229977 |
| Fax |
|
| Email |
bhawani.dr.rathore@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda, Jaipur |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
Jorawer singh gate amer road jaipur |
| 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 bhawani singh rathore |
opd no19 dravyaguna department arogya shalla hospital nia jaipur |
jorawer singh gate jaipur
Jaipur
RAJASTHAN |
9414229977
bhawani.dr.rathore@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics Committee national Institute of ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L819||Disorder of pigmentation, unspecified. Ayurveda Condition: VYANGAH, (2) ICD-10 Condition:L819||Disorder of pigmentation, unspecified. Ayurveda Condition: VYANGAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ingudi Lepa with water. |
In this group patients will be treated with powder of Ingudi phal majja as Lepa (face pack) which will be applied on face with adequate water once a day in morning. The pack will be removed after appearance of dry patches. for one month |
| Comparator Agent |
Jatiphala Lepa with water. |
In this group patients will be treated with powder of Jatiphala seed as Lepa (face pack) which will be applied on face with adequate water once a day in moning. The pack will be removed after appearance of dry patches. for one month |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients presenting Vyanga as clinical features according to Susruta Samhita.
2. Patients of either sex.
3. Patients of age between 18 - 60 years. |
|
| ExclusionCriteria |
| Details |
1. Melasma due to tubercular therapy or malignant cases.
2. Patients having systemic pathogenesis due to allergy.
3. Patients having diagnosis of major illness like IHD, HTN, MI, TB, COPD, DM etc. would be excluded from trial.
4. Diagnosed patients of Carcinoma, Burns, Herpes, Eczema, Psoriasis, Measles, Chickenpox, Leucoderma and Leprosy.
5. Person suffering from any infective or contagious skin disease or under medication with antibiotics, antifungal and steroid.
6. Patients of uncontrolled hormonal disease.
7. Any kind of hereditary skin disorder
8. With present history of pregnancy and chronic constipation.
9. Patient suffering from Melasma more than five year.
10. Patients who are reporting allergy history of trail drugs. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Melasma Area and Severity Index (MASI). in one month ( 4 week)treatment |
Reduction in Melasma Area and Severity Index (MASI). in one month ( 4 week) treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in
face skin colour in 4 weeks |
Changes in face skin colour in 4 weeks |
|
|
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)
|
11/05/2021 |
| 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="1"
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
|
Introduction: -Skin diseases and its’ adverse effects on appearance and personality had been explained by Acharya Sushruta as kshudra rogas for the first time among the Ayurveda amenities. Among those kshudra rogas vyanga is considered as a common skin disorder found in present period. Almost all Acharyas have considered vyanga as a kshudra roga except, Acarya Charaka; he mentions vyanga under raktadhatugata vikara.1 Acharya Sushruta also mention vyanga under raktadhatugata vikara.2 According to Ayurveda concepts, it is manifested due to vitiation of vata and pitta dosha. These doshas vitiated by krodha, aayaas, ushna, tikshna, ruksha dietary habits. Thereby, it results to presence of niruja, tanu, and shyava varna yukta mandala on Mukha pradesh. Vyanga is a common disorder affecting the face area and can be an embarrassing condition. According to the appearance of vyanga, the disease ‘melasma’ can be correlated. In these both conditions, the patches of hyper pigmentation are seen especially on cheeks, nose, forehead and chin. In this research, significance is to know the efficacy of the Ingudi (Balanites aegyptiaca, Linn.Delile) phal majja lepa which mentioned in Rajmartand, which describes Ingudi fruit pulp lepa with water to cure diseases of face Vyanga (Melasma)4 and Jatiphala (Myristica fragrans,Houtt.) seed lepa is mentioned in Chakardatta Chikitsa which describes Jatiphala lepa with water cure Nilli and Vyanga. Need of Study: - Jathipala is being used by the people in many skin disorders for a long time. Alternatively, there are many references of Ingudi are also available in classics in relation to skin disorders and easily available. Hence, this clinical study will be taken to compare the effect of Ingudi lepa and Jatiphala lepa on Vaynga to provide a safe, cost effective treatment. Hypothesis Null Hypothesis Ho: There is no difference between the Ingudi lepa and Jatiphala Lepa in the Melasma Area and Severity Index (MASI). Primary outcome: Reduction in Melasma Area and Severity Index (MASI). Secondary outcome: Changes in skin colour . MATERIAL AND METHOD:- Conceptual study- Drug Review- Critical review of the trial drugs will be done in the research work under Vyanga. Ingudi phal majja (mesocarp) (Balanites aegyptica, Linn.Delile) commonly known as Hingot in Hindi and Jatiphala (Myristica fragrans,Houtt.) beeja (seed )commonly known as Nutmeg in English will be elaborated under drug review. Outcomes of The Study: - Primary outcome: Reduction in Melasma Area and Severity Index (MASI). Secondary outcome: Changes in skin colour . Assessment criteria: 1. Photograph will be taken before the treatment and after the treatment in day light from same distance. 2. Melasma Area and Severity Index (MASI).
All data observed will be recorded. The study area of patients will be digitally photograph on each observation day and recorded. In these, findings prior and after the treatment will be compared and statistically analyzed for their significance to draw conclusion. |