| CTRI Number |
CTRI/2025/08/093922 [Registered on: 29/08/2025] Trial Registered Prospectively |
| Last Modified On: |
28/08/2025 |
| 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
|
Evaluation of Efficacy and Safety of Majoon e Ushba orally and locally paste in the management of fungal infection. |
|
Scientific Title of Study
|
Evaluation of efficacy and safety of Majoon e Ushba orally and Zimad (a herbomineral unani formulation) topically in the management of Quba (Tinea corporis) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abdul Rehman Ali |
| Designation |
MD Scholar |
| Affiliation |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Bhopal |
| 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 462003
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
8085182239 |
| Fax |
|
| Email |
ar5373140@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Munawwar Gauri |
| Designation |
Assistant Professor |
| Affiliation |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Bhopal |
| 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 462003
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9981817255 |
| Fax |
|
| Email |
mgauri52@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Abdul Rehman Ali |
| Designation |
MD Scholar |
| Affiliation |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Bhopal |
| 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 462003
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
8085182239 |
| Fax |
|
| Email |
ar5373140@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Bhopal Madhya Pradesh Medical Science University Jabalpur 482003 Madhya Pradesh India |
|
|
Primary Sponsor
|
| Name |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Bhopal |
| Address |
Hakim Syed ziaul Hasan Government Unani Medical College and Hospital Ayush Campus Kolar Bypass Road Bhopal 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 |
| Dr Abdul Rehman Ali |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital |
OPD No. 05 Department of Amraz e Jild wa Tazeeniyat of Hakim Syed Ziaul Hasan Government Autonomous Unani Medical College and Hospital Bhopal
Bhopal
MADHYA PRADESH |
8085182239
ar5373140@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: L088||Other specified local infections of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Clotrimazole 1% cream |
Clotrimazole 1% cream will be procured from the market. Cream should be applied on affected area 2 times every day for 5 weeks |
| Intervention |
Zimad contain following ingredients: 1.Suhaga (Borax)3gm 2.Murdar sang (Litharge)3gm 3.Kath safaid (Acacia catechu)3gm 4.Tukhm panwad (Cassiatora)3gm 5.Gandhak (Sulpher)3gm 6.Raskapoor(Calomel)250mg 7.Ghee (Clarified butter)60gm along with Majoon Ushba 5gm twice a day orally. |
A topical unani formulation zimad which consists of fine powder of Suhaga, Murdar sang, Kath safaid, Tukhm panwad , Gandhak and Raskapoor mixed with Ghee in required amount to make a paste and applied on affected area 2 times every day along with Majoon Ushba 5gm twice a day orally after breakfast & dinner for 5 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Clinically diagnosed and potassium hydroxide test (KOH)
2.Confirmed cases of dermatophytosis
3.Subjects who have agreed to sign the informed consent form |
|
| ExclusionCriteria |
| Details |
1.Patients suffering from concomitant diseases like psoriasis and eczema.
2.Patients suffering from severe systemic and metabolic diseases like diabetes mellitus, hepato renal dysfunctions etc.
3.Pregnant and lactating women.
4.Patients who have received any topical antifungal therapy within last 2 weeks or oral antifungal therapy in the previous 4 weeks. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. DSS (Dermatophytosis severity score)
2. Mycological cure (KOH test) |
On Days 1, 14 and 35 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| DLQI score (Dermatologically life quality index) |
1st day and 35 day |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
08/09/2025 |
| 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
|
Quba, also known as Dermatophytosis, is a common fungal infection that affects the keratinized tissues of the body such as skin, hair, and nails. It is caused by a group of fungi known as dermatophytes, which belong to three main general Trichophyton, Microsporum, and Epidermophyton. Globally, around 20 to 25 percent of the population is affected by this condition. In India, the prevalence is particularly high, ranging from 36.6 to 78.4 percent. The infection is classified based on the site affected, such as Tinea capitis for the scalp, Tinea corporis for the body, and others. Tinea corporis is reported to be the most common type in India. It presents as circular lesions on the trunk with red raised borders and a clear center, often accompanied by itching, scaling, and discomfort. In Unani medicine, Quba is described as a type of rough, hyperpigmented patch that is itchy but painless. It is generally circular and caused by factors such as excess heat in the blood, phlegmatic imbalance, and other humoral disturbances. Despite the availability of modern antifungal medicines, the prognosis of dermatophytosis remains poor and the misuse of corticosteroids often worsens the condition. These treatments also carry potential side effects. This study was undertaken to evaluate the safety and effectiveness of Unani formulations, specifically oral Majoon e Ushba and topical Zimad, in managing Quba. These formulations have been traditionally used and are considered safe. The aim is to offer a reliable, safe, and effective alternative treatment for this common condition. |