| CTRI Number |
CTRI/2019/05/019385 [Registered on: 27/05/2019] Trial Registered Prospectively |
| Last Modified On: |
26/05/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical Trial of Mukhakantiprada lepa and its cream on human patients of hyperpigmentation on face |
|
Scientific Title of Study
|
Pharmaceutico-analytical study and randomized controlled clinical trial of modified mukhakantiprada lepa in vyanga |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Richa Arvind Agrawal |
| Designation |
MD Scholar |
| Affiliation |
Sumatibhai shah ayurved Mahavidyalaya hadapsar pune |
| Address |
Sumatibhai Shah Ayurvedic College, Hadapsar Dept-Rasashastra and Bhaisjya kalpana 2nd floor (2nd year) PUNE.
Near railway station road navapur,Dist-nandurbar
Pune
MAHARASHTRA
411028
India |
| Phone |
8379901500 |
| Fax |
|
| Email |
agrawalricha994@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyoti Brijesh Gavali |
| Designation |
Asso. Professor |
| Affiliation |
Maharashtra university of Health Sciences,Nashik |
| Address |
Sumatibhai Shah Ayurved college,Hadapsar Dept of Rasashastra and Bhaisjya kalpana 2nd year (2nd floor)
Pune
MAHARASHTRA
411028
India |
| Phone |
7709819535 |
| Fax |
|
| Email |
jbgavali@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Richa Arvind Agrawal |
| Designation |
MD Scholar |
| Affiliation |
Sumatibhai shah ayurved Mahavidyalaya hadapsar pune |
| Address |
Sumatibhai shah ayurved college, Hadapsar Dept of Rasashastra and Bhaisjyakalpana 2nd year (2nd floor)
Near railway station road navapur,Dist-nandurbar
Pune
MAHARASHTRA
411028
India |
| Phone |
8379901500 |
| Fax |
|
| Email |
agrawalricha994@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Richa Agrawal
Vidyavihar colony no.1 behind sane guruji hospital Malwadi Hadapsar-411028 |
|
|
Primary Sponsor
|
| Name |
Sane guruji Arogya kendra |
| Address |
Dept of Kayachikitsa (Opd no-2)
Near S.M.Joshi college Hadapsar-411028 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Richa Arvind Agrawal |
Sane guruji arogya kendra,hapasar pune |
Sane guruji arogya kendra malwadi hadapsar pune
Dept of Kayachikitsa
Opd no-2
Ground floor
Pune
MAHARASHTRA |
8379901500
agrawalricha994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SSAM Ethics commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L81||Other disorders of pigmentation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Modified form of lepa in the form of cream |
Cream will be applied on affected part on face once in a day.
Concentration of cream will be 33.33% w/w.
Dose-As required as it is depended on size and number of lesions.
Duration- Rubbed over lesions until it is absorbed. |
| Comparator Agent |
Mukhkantiprada lepa |
The lepa will be applied on affected area once in a day in the form of paste.
concentartion of lepa will be 40% w/w.
Dose-As required as it is depended on number and size of lesions.
Duration-It should be washed off after it dries. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient showing signs and symptoms of vyanga as per classical text like Niruja(painless),Mandala(round patch),Shyava(blotchy brown pigmentation) on face |
|
| ExclusionCriteria |
| Details |
1.Birth mark
2.Any known facial injuries with scares
3.Hormonal therapy and patient with systemic disorders.
4.Patients on any other medication for the same problem during the study
5.Pregnant ladies |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Colour of lesion(patch) |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Number of lesions(patch)
2.Size of lesion(patch)
2.Size of lesion(patch)
3.Colour of lesion(patch) |
30 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/06/2019 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet submitted
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
There are two groups in this study with 30 patients in each group, Group A will be treated with mukhkantiprada lepa and group B will be treated with Modified form of lepa as a cream. Patients will be selected for group through generated randomized number chart.Drugs for both group will be given for 30 days with follow up on 15th and 30th day of the trial. Size of lesion,colour of lesion and number of patches will be recorded on first and follow up days.
Mukhkantiprada lepa ia mentioned by ahranghshr in vyanga but due to day today life style,shelf life of drugs,lack of time it ia difficult to use kela by people.As mukhkantiprada cream(novel dosage form)will be used as alternative source of drug. |