| CTRI Number |
CTRI/2024/06/068679 [Registered on: 11/06/2024] Trial Registered Prospectively |
| Last Modified On: |
11/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical study of Unani Formulation in Tinea Corporis |
|
Scientific Title of Study
|
A Randomized, Parallel Group, Open Label, Active Controlled Clinical Study To Evaluate The Safety And Efficacy Of A Topical Unani Formulation In The Management Of QÅ«bÄ (Tinea Corporis) |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Madeeha Bano |
| Designation |
Pg Scholar |
| Affiliation |
National Research Institute Of Unani Medicine For Skin Disorders |
| Address |
Department Of Moalajat, National Research Institute Of Unani
Medicine For Skin Disorders, A.G. Colony Rd., Opposite ESI
Hospital, Errgadda, Hyderabad-500038.
Hyderabad
TELANGANA
500038
India
Hyderabad
TELANGANA
500038
India |
| Phone |
8756476726 |
| Fax |
|
| Email |
doctormadeeha33@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Mohammad Nasar |
| Designation |
Professor |
| Affiliation |
National Research Institute Of Unani Medicine For Skin Disorders |
| Address |
Department Of Moalajat, National Research Institute Of Unani
Medicine For Skin Disorders, A.G. Colony Rd., Opposite ESI
Hospital, Errgadda, Hyderabad-500038.
Hyderabad
TELANGANA
500038
India
Hyderabad
TELANGANA
500038
India |
| Phone |
8328446962 |
| Fax |
|
| Email |
drnasar.nriumsd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madeeha Bano |
| Designation |
Pg Scholar |
| Affiliation |
National Research Institute Of Unani Medicine For Skin Disorders |
| Address |
Department Of Moalajat, National Research Institute Of Unani
Medicine For Skin Disorders, A.G. Colony Rd., Opposite ESI
Hospital, Errgadda, Hyderabad-500038.
Hyderabad
TELANGANA
500038
India
Hyderabad
TELANGANA
500038
India |
| Phone |
8756476726 |
| Fax |
|
| Email |
doctormadeeha33@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Research Institute Of Unani Medicine For Skin Disorders
|
|
|
Primary Sponsor
|
| Name |
National Research Institute Of Unani Medicine For Skin Disorders |
| Address |
A.G. Colony Road, Opposite ESI Hospital, Erragadda,
Hyderabad-500038
|
| 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 Madeeha Bano |
National Research Institute Of Unani Medicine For Skin Disorders |
OPD & IPD of
Department Of
Moalajat, National
Research Institute Of
Unani Medicine For
Skin Disorders. A.G.
Colony Road, Opposite
ESI Hospital,
Erragadda,
Hyderabad-500038
Hyderabad
TELANGANA
Hyderabad
TELANGANA |
8756476726
doctormadeeha33@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communication Of Decision Of Institutional Ethics Committee (IEC) |
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 |
Terbinafine 1% |
Dosage Form:Cream,Dose:As per required twice daily Mode of Administration: Topical Duration of Therapy:6 weeks |
| Intervention |
Topical Unani Formulation(homogenous powder as a Liniment in water) |
Composition:Tukhm-i-panwad (Foetid cassia)Amla (Indian gooseberry) Laakh (Kerria lac insect) Zeera (cuminum cyminum)
Dose:As per required twice daily Mode of Administration: Topical Duration of Therapy:6 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Participants of any gender in age group of 18-60 years
2 Participants of QÅ«bÄ(Tinea Corporis) having circumscribed lesions with any of the following signs and symptoms on body and limbs:
a Presence of pruritus and burning
b Presence of scales
c Presence of central clearing
d Erythematous papules
3 Participants with Positive KOH (10%) Smear Microscopy of Skin Scrapping from the active lesion for Dermatophytic hyphae
Participants who are willing to participate and comply with the protocol and sign to IEC approved ICF. |
|
| ExclusionCriteria |
| Details |
The following patients will be excluded:
Age below 18 years and above 60 years
Patients with other form of tinea infection like tinea cruris (groin), tinea capitis (head), tinea pedis (foot), tinea mannum (hands), tinea unguium (nails), tinea barbae (beard), tinea faciei (face),etc.
Patient with other concomitant diseases like psoriasis & eczema
Patients who have received any topical antifungal therapy within last 2 weeks or oral antifungal therapy in the previous 4 weeks
Patients with known active pulmonary/ cardiovascular/ liver/ renal or neurological diseases
Known cases of Diabetes Mellitus or other immunocompromised disorders (HIV/ AIDS, etc.)/ Malignancies
Patients with long-term history of steroid, cytotoxic and immunosuppressive therapy
History of hypersensitivity to either itraconazole or any test drug
Pregnant or lactating women, and women desiring pregnancy
Participants not willing to give consent and to attend treatment schedule regularly
|
|
|
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 |
1. Total Signs & Symptoms Score (TSSS)
(Clinical Cure)
2. Conversion to Negative Mycology
(Mycological Cure)
|
TSSS At baseline 2nd, 4th and on 6th weeks.
Mycological Cure at baseline and on 6th week.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| DLQI (Dermatology Life Quality Index) |
At baseline 2nd, 4th and on 6th weeks. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
19/08/2024 |
| 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="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
|
Tinea /ringworm infection is caused by a distinct class of fungi, the dermatophytes. They thrive in the keratin layer of the epidermis, nails and hair. Trichophyton, Microsporum, and Epidermophyton, and affecting 20–25% of the world population with varying geographic distribution. There are several unani formulations are being used in the management of this disease but most of them are lack of evidence based clinical trials, Hence, the present study is entitled to evaluate the safety and efficacy of Unani Formulation in the management of QÅ«bÄ. |