| CTRI Number |
CTRI/2025/01/079701 [Registered on: 29/01/2025] Trial Registered Prospectively |
| Last Modified On: |
28/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Study on the Efficacy of Sharbat Unnab and Herbal Formulations in Managing Atopic Dermatitis |
|
Scientific Title of Study
|
Efficacy of Sharbat Unnab with Lazuq of Kafoor, Rasot, Luaab Aspgol, Luaab Bartang in Atopic Dermatitis – A Randomized Single-Blind Placebo-Controlled Clinical Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR NIKHAT ARA |
| Designation |
PG Scholar |
| Affiliation |
National Institute Of Unani Medicine |
| Address |
Department Of Amraze Jild Wa Tazeeniyat National Institute of Unani Medicine Kottigepalya Magadi Main Road Bangalore Karnataka 560091 India
Bangalore
KARNATAKA
560091
India |
| Phone |
9661399416 |
| Fax |
|
| Email |
nikhataratajpur@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Mohd Aleemuddin Quamari |
| Designation |
HOD Amraze Jild Wa Tazeeniyat & Moalajat (I/C) |
| Affiliation |
National Institute Of Unani Medicine |
| Address |
Department Of Amraze Jild Wa Tazeeniyat National Institute of Unani Medicine Kottigepalya Magadi Main Road Bangalore Karnataka 560091 India
Bangalore
KARNATAKA
560091
India |
| Phone |
9341072974 |
| Fax |
|
| Email |
drmaquamri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Mohd Aleemuddin Quamari |
| Designation |
HOD Amraze Jild Wa Tazeeniyat & Moalajat (I/C) |
| Affiliation |
National Institute Of Unani Medicine |
| Address |
Department Of Amraze Jild Wa Tazeeniyat National Institute of Unani Medicine Kottigepalya Magadi Main Road Bangalore Karnataka 560091 India
Bangalore
KARNATAKA
560091
India |
| Phone |
9341072974 |
| Fax |
|
| Email |
drmaquamri@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Unani Medicine
Kottigepalya, Magadi Main Road Banglore 560091 Karnataka India |
|
|
Primary Sponsor
|
| Name |
National Institute Of Unani Medicine |
| Address |
Department Of Amraze Jild Wa Tazeeniyat National Institute of Unani Medicine Kottigepalya Magadi Main Road Bangalore Karnataka 560091 India |
| 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 Nikhat Ara |
National Institute Of Unani Medicine |
Department Of Amraze Jild Wa Tazeeniyat OPD/IPD National Institute of Unani Medicine Kottigepalya Magadi Main Road Bangalore Karnataka 560091 India
Bangalore
KARNATAKA |
09341072974
drmaquamri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communication of Decision of the Institutional Ethics Committee (IEC) For Biomedical Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L209||Atopic dermatitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo (caramel syrup orally and local application of liquid paraffin) |
Oral administration of Carmel syrup is given:
•5ml (5 yrs)
•10ml (5-10yrs)
•15ml (10 yrs) twice a day after meal.
Apply petroleum jelly / liquid paraffin locally on affected area daily twice a day.
|
| Intervention |
Sharbat unnab + Lazuq/Lasuq of kafoor, rasot, Luaab aspgol, Luaab bartang |
Equal amount of kafoor and rasot (1:1) mixed together in the Luaab aspgol and Luaab bartang and stirred properly then soak a piece of cloth or cotton gauge in the same and apply the cotton cloth or cotton gauge locally on affected area, until the soaked cloth or cotton gauge gets dried. This should be applied twice daily. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects with age between 2-18 years.
2.All gender.
3.Diagnosed cases of Atopic dermatitis as per Hannifin and Rajika Criteria.
|
|
| ExclusionCriteria |
| Details |
1.Subjects who had previously applied topical treatments like corticosteroid or calcineurin inhibitors before 1 month of study.
2.Subjects who took following medication like systemic corticosteroids, and immunosuppressants, prior to 1 month of study.
3.Subjects who have types of dermatitis other than Atopic dermatitis-like stasis dermatitis, seborrheic dermatitis, contact dermatitis, nummular dermatitis.
4.Subjects who have Type 1 DM.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.Decrease in SCORAD index |
Follow up: 0TH Day and 30th Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Decrease in Photography
2.POEM Questionnaire
|
1.Decrease in Photography
Follow up 0th Day,7th Day,14th Day,21th Day,28th Day
2.POEM Questionnaire
Follow up 0th Day,30th DAY
|
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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)
|
17/02/2025 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Purpose: To evaluate the efficacy of Sharbat unnab with Lazuq or Lasuq of kafoor, rasot, Luaab aspgol, Luaab bartang in comparison with placebo. Design: A Randomized Single Blind Placebo Controlled Clinical Trial. Intervention: Test Group: Sharbat unnab with Lazuqor Lasuq of kafoor, rasot, Luaab aspgol, Luaab bartang, Control Group: Placebo (caramel syrup orally and local application of liquid paraffin). Main outcome measures: Primary endpoint - Decrease in SCORAD index
Secondary endpoint 1. Decrease in Photography 2. POEM Questionnaire |