| CTRI Number |
CTRI/2021/01/030543 [Registered on: 18/01/2021] Trial Registered Prospectively |
| Last Modified On: |
11/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Dwiharidradi Kalk lep and Kumkumadi Tail used for treatment of pimples (Acnevulgaris ) |
|
Scientific Title of Study
|
A Clinico comparative study of Dwiharidradi Kalka lepam and Kumkumadi Tailam in the management of mukhadushika w.s.r. to Acnevulgaris |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manish Choudhari |
| Designation |
Post graduation scholar |
| Affiliation |
Govt. Dhanwantri Ayurved college and hospital |
| Address |
OPD no. 27 Kayachikitsa deparment Govt.Dhanwantari Ayurvedic Hospital Chimanganj thane ke piche Ujjain
OPD no. 27 Kayachikitsa deparment Govt.Dhanwantari Ayurvedic Hospital Chimanganj thane ke piche Ujjain
Ujjain
MADHYA PRADESH
--456001
India |
| Phone |
8871467316 |
| Fax |
0 |
| Email |
choudhari.manish007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naresh Jain |
| Designation |
Associate professor |
| Affiliation |
Govt. Dhanwantri Ayurved college and hospital |
| Address |
Room no. 1 1st floor Kayachikitsa department Govt Dhanwantri Ayurved medical college Mangalnath road
Room no. 1 1st floor Kayachikitsa department Govt Dhanwantri Ayurved medical college Mangalnath road
Ujjain
MADHYA PRADESH
456006
India |
| Phone |
9826064756 |
| Fax |
0 |
| Email |
nareshjainujn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Naresh Jain |
| Designation |
Associate professor |
| Affiliation |
Govt. Dhanwantri Ayurved college and hospital |
| Address |
Room no 1 1st floor Kayachikitsa department Govt Dhanwantri Ayurved medical college Mangalnath road
1st floor Kayachikitsa department Govt Dhanwantri Ayurved medical college Mangalnath road
Ujjain
MADHYA PRADESH
456006
India |
| Phone |
9826064756 |
| Fax |
0 |
| Email |
nareshjainujn@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt Dhanwantri Ayurved medical college and Hospital Ujjain |
|
|
Primary Sponsor
|
| Name |
Govt Dhanwantri Ayurved medical college and Hospital Ujjain |
| Address |
Mangalnath road Ujjain Madhya pradesh |
| 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 |
| Manish Choudhari |
Govt Dhanwantri Ayurved Hospital Ujjain |
OPD NO 27 Kayachikitsa department Govt Dhanwantri Ayurved Hospital Chimanganj Thane Ke Pichhe
Ujjain
MADHYA PRADESH |
8871467316
0
choudhari.manish007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethical Committee Govt Dhanwantri Ayurved medical college and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L449||Papulosquamous disorder, unspecified. Ayurveda Condition: Mukhadushika, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Drop of Kumkumadi tail |
5-15 Drops of Kumkumadi tail used in locally daily for 4 weeks |
| Intervention |
Dwiharidradi kalka lep
|
Dwiharidradi kalka lep used in locally daily (1/4 finger proof) for 4 weeks
|
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
32.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients presenting with classical sign and symptoms of Mukhadushika
2 total Acne lesion count 2 -40 |
|
| ExclusionCriteria |
| Details |
1 Patient below 12 year and above 32 year of age
2 Pregnant women and lactating mother
3 Patients on steroid therapy
4 Patients who have undergone surgery |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy - reducing a new by being mukhadushika |
Total study period 2 years
Treatment period 1 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Healing a acne papules, pustules and black spots |
Total study period 2 years
Treatment period 1 months |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
05/04/2021 |
| 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="2"
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
|
This study is a randomized interventional clinical trial to evaluate the effect of Dwiharidradi Kalk lepam and Kumkumadi Tailam in the management of Mukhadushika w.s.r. to Acnevulgaris. Total 40 patients will be enrolled in present study. Selected patients will be devided in two groups on the basis of computer generated randomization.Group A - 20 patients will be given Dwiharidradi Kalk lep used in locally daily (1/4 self finger proof)
Group B - 20 patients will be given 5-15 drops of Kumkumadi Tail used in locally daily |