| CTRI Number |
CTRI/2019/12/022520 [Registered on: 26/12/2019] Trial Registered Prospectively |
| Last Modified On: |
01/12/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of manibhadra aveleha with mansheeladi ointment in shwitra |
|
Scientific Title of Study
|
A clinical study on the efficacy of manibhadra aveleha along with mansheeladi ointment in the management of shwitra |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shallu sharma |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Department of Kaumarbhritya Parul Institute of Ayurveda Parul University Limda Vadodra Gujarat 391760
Department of Kaumarbhritya Parul Institute of Ayurveda Parul University Limda Vadodra Gujarat 391760
Vadodara
GUJARAT
391760
India |
| Phone |
08968234420 |
| Fax |
02668-260201 |
| Email |
shallu01233@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SWAPNIL CR |
| Designation |
Assistant Professor |
| Affiliation |
PARUL |
| Address |
Department of Kaumarbhritya Parul Institute of Ayurveda ,Parul University Limda Vadodra Gujarat 391760
Department of Kaumarbhritya Parul Institute of Ayurveda ,Parul University Limda Vadodra Gujarat 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9879340491 |
| Fax |
02668-260201 |
| Email |
neonatecare99@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SWAPNIL CR |
| Designation |
Assistant Professor |
| Affiliation |
PARUL |
| Address |
Department of Kaumarbhritya Parul Institute of Ayurveda ,Parul University Limda Vadodra Gujarat 391760
Department of Kaumarbhritya Parul Institute of Ayurveda ,Parul University Limda Vadodra Gujarat 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9879340491 |
| Fax |
02668-260201 |
| Email |
neonatecare99@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Institute Of Ayurved, Parul University Limda Vadodra Gujarat 391760 |
|
|
Primary Sponsor
|
| Name |
Parul Institute Of Ayurved |
| Address |
Department of Kaumarbhritya Parul Institute of Ayurveda ,Parul University Limda Ladodra Gujarat 391760 |
| Type of Sponsor |
Private 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 SWAPNIL CR |
Parul Ayurved Hospital |
Department of Kaumarbhritya Parul Institute of Ayurveda ,Parul University Limda Vadodra Gujarat 391760
Vadodara
GUJARAT |
9879340491
02668-260201
neonatecare99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee for human research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L80||Vitiligo, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Manibhadra aveleha along with mansheeladi ointment. |
20 patient will be treated with manibhadra aveleha along with mansheeladi ointment in the management of shwitra. Manibhadra aveleha dose will be administrated by mouth and dose has been decided by as per age from 5 years to 16 years.
AGE DOSE
5years 7.5gm in three
divided doses
6yrs 9gm in three
divided doses
7yrs 10.5gm in three
divided doses
8yrs 12gm in three
divided doses
9yrs 13.5gm in three
divided doses
10yrs 15gm in three
divided doses
11yrs 16.5gm in three
divided doses
12yrs 18gm in three
divided doses
13yrs 19.5gm in three
divided doses
14yrs 21gm in three
divided doses
15yrs 22.5gm in three
divided doses
16yrs 24gm in three
divided doses
Mansheeladi ointment for local application quantity sufficient twice a day avoid to go in sunlight Duration of the therapy should be 2 months with 15 days of follow up within it. |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
PATIENT ABOVE 5 YEARS TO 16 YEARS.
PATIENTS WITH SINGLE AS WELL AS MULTIPLE PATCHES WITH CHRONICITY OF WITHIN 5 YEARS. |
|
| ExclusionCriteria |
| Details |
Secondary skin infectious diseases.
Patients having patches on genitals eye, axilla.
Patients having skin lesions more than 15% body surface area. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| By giving manibhadra aveleha with mansheeladi ointment skin patches will reduce. |
2 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reducing the size of the patches. |
2 months. |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
26/12/2019 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Skin
is a largest organ of our body. The beauty and attraction of individual depends upon skin’s health including physical and psychological health Skin
complaints affect all ages from neonates to the elderly and cause harm in
number of ways, such discomfort, disfigurement, disability etc. Shwitra is one of skin disorder with great bad impact on human life.
The
Shwitra is the group of symptoms which manifest as white spots on the skin and
causes cosmetic imbalance body which ultimately leads to many socialized
psychological stigma in life of the patientThe
signs and symptoms of Shwitra are; white, red or coppery red colored patches on the skin, destruction
of the skin lustre,
loss and
discoloration of the hair, roughness, dryness, itching and burning sensation of
the patches.
According
to Modern dermatology, Shwitra can be correlated with Vitiligo and Leukoderma. |