| CTRI Number |
CTRI/2024/03/064223 [Registered on: 15/03/2024] Trial Registered Prospectively |
| Last Modified On: |
12/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Treatment of Acne Vulgaris (pimple) with Unani medicine. |
|
Scientific Title of Study
|
Comparative study of Topical Versus Topical and Oral Unani formulation in Busoore labaniya (Acne Vulgaris) |
| 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 Afeefa Kazmi |
| Designation |
PG Scholar |
| Affiliation |
Govt. Tibbi College and Hospital, Patna |
| Address |
Department of Moalajat (Medicine)
Govt. Tibbi College and Hospital
Kadamkuan
Patna
Patna
BIHAR
800003
India |
| Phone |
7895077134 |
| Fax |
|
| Email |
afeefa.kazmi123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Md Tanwir alam |
| Designation |
HoD cum Principal Govt. Tibbi College, Patna |
| Affiliation |
Govt. Tibbi College and Hospital, Patna |
| Address |
Department of Tahaffuzi wa samaji tib (preventive and social Medicine)
Govt. Tibbi College and Hospital
Kadamkuan
Patna
Patna
BIHAR
800003
India |
| Phone |
7543854407 |
| Fax |
|
| Email |
tanveernium3133@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Md Razi Ahmad |
| Designation |
Assistant professor |
| Affiliation |
Govt. Tibbi College and Hospital, Patna |
| Address |
Department of Moalajat (Medicine)
Govt. Tibbi College and Hospital
Kadamkuan
Patna
Patna
BIHAR
800003
India |
| Phone |
7909035622 |
| Fax |
|
| Email |
dr.razi.ahmed91@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt. Tibbi College and Hospital, Patna |
|
|
Primary Sponsor
|
| Name |
Govt. Tibbi College and Hospital, Patna |
| Address |
Govt. Tibbi College and Hospital, Patna
Bihar
800003 |
| Type of Sponsor |
Other [Govt. Tibbi College and Hospital, Patna ] |
|
|
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 Afeefa Kazmi |
Govt. Tibbi College and Hospital, Patna |
Department of moalajat (medicine), Govt. Tibbi College and Hospital, Patna
Patna
BIHAR |
7895077134
afeefa.kazmi123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Govt. Tibbi College and Hospital, Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L700||Acne vulgaris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Topical:- Paste of powdered form of (Shoniz, Naushadar, Bura Armani with Sirka) |
Paste of Unani formulation (Shoniz, Naushadar, Bura Armani with Sirka) will be applied on the Acne once at night for 45 minutes & then wash with water. Patient will be instructed to avoid contact with eyes, ears, nostrils & mouth. The paste will be applied daily for 2 weeks after that on an alternate basis till the end of the study (28 days). |
| Comparator Agent |
Topical:- Paste of powdered form of (Shoniz, Naushadar, Bura Armani with Sirka) with Oral:- Itrifal Shahatra 5gm twice a day |
Paste of Unani formulation will be applied on the Acne once at night for 45 minutes & then wash with water. Patient will be instructed to avoid contact with eyes, ears, nostrils & mouth. The paste will be applied daily for 2 weeks after that on an alternate basis till the end of the study (28 days).
Itrifal Shahatra 5gm twice a day till 28 days. |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
patients age group 14-40
patients all genders
diagnosed cases of acne
clinically stable patients
patients or guardians who agree to sign informed consent form and follow protocol |
|
| ExclusionCriteria |
| Details |
patients who do not cooperate
less than 14 and more than 40 years old
patients having local infection
patients having PCOD, autoimmune disorders, diabetic patients
pregnant and lactating mothers
patients on corticosteroid therapy
or taking OCPs
patients suffering from other concomitant diseases like acne rosacea, acne fulminans, acne necrotica, psoriasis, eczema etc |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| changes in the Cook et al., system of acne grading method. |
changes in the Cook et al., system of acne grading method, every week from the baseline to 4th week (28 days) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in subjective parameters assessed clinically. |
After 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
22/03/2024 |
| 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="0"
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
|
In this randomized comparative clinical trial on Busoore labaniya (Acne vulgaris), subjects will be enrolled according to the selection criteria, a total of 100 patients will be enrolled which further will be divided into 2 groups group A and B respectively 50 patients in each group, and (group A will be given paste of (shoniz, naushadar, bura armani with sirka) topically for 28 days (on an initial 2 weeks regular basis while later 2 weeks on alternate basis) and group B will be given the same topical drug with Itrifal Shahatara 5gm twice a day for 28 days. to determine the better drug for acne vulgaris. |