| CTRI Number |
CTRI/2025/08/093615 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
25/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Therapeutic evaluation of Topical Paste of Cuttle fish bone and Turmeric Curcuma Longa in Acne Vulgaris |
|
Scientific Title of Study
|
Therapeutic evaluation of Topical Unani Formulation Dhimad of Kafe Dariya (Cuttle fish bone) and Haldi (Turmeric Curcuma Longa) in Buthur Labaniyya (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 |
Bushra khan |
| Designation |
PG Scholar |
| Affiliation |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital |
| Address |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus kolar bypass road Bhopal
Madhya Pradesh
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus kolar bypass road Bhopal
Madhya Pradesh
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9644194671 |
| Fax |
|
| Email |
khandrbushraji@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohammad Anzar Husain |
| Designation |
Professor and HOD |
| Affiliation |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital |
| Address |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus kolar bypass road Bhopal
Madhya Pradesh
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus kolar bypass road Bhopal
Madhya Pradesh
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
7000097052 |
| Fax |
|
| Email |
mohdanzarhusain@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Bushra Khan |
| Designation |
PG Scholar |
| Affiliation |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital |
| Address |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus kolar bypass road Bhopal
Madhya Pradesh
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus kolar bypass road Bhopal Madhya Pradesh
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9644194671 |
| Fax |
|
| Email |
khandrbushraji@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Bhopal Medical Science University Jabalpur Madhya Pradesh 482003 India |
|
|
Primary Sponsor
|
| Name |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospita |
| Address |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus kolar bypass road Bhopal Madhya Pradesh 462003 |
| 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 |
| Dr Bushra khan |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital |
OPD 05 Amraz e jild wa Tazeeniyat Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Bhopal
Bhopal
MADHYA PRADESH |
9644194671
khandrbushraji@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital |
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 |
| Comparator Agent |
Clindamycin 1% gel |
Patient will be asked to wash his or her face in order to remove dirt, sweat or any applied cream and then after drying the affected part by the clean towel and then patients will be instructed to apply Clindamycin 1% gel topically only on the affected area, once at night and will be asked to leave it overnight followed by washing in the morning |
| Intervention |
Dhimad Contain Following ingredient 1. Kafe Dariya (Cuttle fish bone) 2. Haldi (Turmeric: Curcuma Longa) 3. Arq e Gulab |
Patient will be asked to wash his or her face in order to remove dirt, sweat any applied cream and then he will apply the test drug (Dhimad) after drying the affected part by the clean towel and then patients will be instructed to apply 5 to 10gram (keeping in view of the area involved) of this Dhimad (paste) mixed with Arq e Gulab on the acne affected area once at night and will be asked to leave it overnight followed by washing in the morning. |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Mild to moderate acne as defined by the Global Acne Grading System (GAGS) scale.
2. Patients willing to sign the informed consent form.
3. In Case of minor consent will be taken from parents or the guardian of the patient.
|
|
| ExclusionCriteria |
| Details |
1)Patients suffering from any skin disease like vitiligo, psoriasis, eczema, etc.
2) Immunocompromised condition
3) Any active psychiatric illness.
4) Pregnant and lactating women.
5) Patients with any systemic illness such as the known case of DM, HTN, etc. which might interfere with the follow-up and assessment during our study.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Global Acne Grading System Scale (GAGS) |
On Day 0,7,14 and 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| DLQI (Dermatology Life Quality Index) |
On Days 0,7,14 and 28. |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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 |
|
Date of First Enrollment (India)
|
05/09/2025 |
| 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="0"
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
|
Acne vulgaris, or Buthur Labniya in Unani medicine, is a common dermatological disorder primarily affecting adolescents. It results from irritation of the pilosebaceous unit, leading to increased sebum production, abnormal keratinization, and colonization by Propionibacterium acnes. In Unani philosophy, acne is caused by an imbalance of bodily humors, with suppurative material ascending to the skin due to bukharat (bodily vapors). Globally, acne affects approximately 9.4 percent of the population, with teenagers showing up to 85 percent prevalence, largely due to hormonal changes. Clinically, acne manifests as comedones, papules, pustules, nodules, and cysts, with severe cases potentially causing scarring. Conventional management involves topical treatments like retinoids, antibiotics, and benzoyl peroxide, while moderate to severe cases may require oral antibiotics or hormonal therapy. Isotretinoin is reserved for treatment-resistant cases but carries risks of erythema, peeling, dryness, and other adverse effects. Resistance to antibiotics further limits long-term use, emphasizing the need for alternative therapies. Unani medicine offers effective, oil free formulations for acne management, focusing on blood purification, desiccation, and scar prevention. One such formulation is Dhimad, a homogenous paste made from fine powder of Kafe Dariya (Cuttlefish bone) and Haldi (Turmeric), mixed with Arq e Gulab. Applied topically at night, it targets acne lesions and is left overnight. The control drug in studies is Clindamycin 1% gel, applied similarly. These interventions demonstrate the potential of combining classical Unani remedies with modern therapeutic principles for safe and holistic acne management. |