| CTRI Number |
CTRI/2023/04/051529 [Registered on: 12/04/2023] Trial Registered Prospectively |
| Last Modified On: |
11/04/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani
Diagnostic |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of QÅ«bÄ- (Dermatophytosis) by Unani medicine - Habbe Kibreet Sagheer |
|
Scientific Title of Study
|
Clinical Validation of Unani Pharmacopoeial Formulation Habbe Kibreet Sagheer in QÅ«bÄ- (Dermatophytosis) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HKS/QUBA/SKGN/CLNVAL/CCRUM 2020-2021 Ver 01 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Syed Gunawaz Ahmed |
| Designation |
Research Officer S4 |
| Affiliation |
National Research Institute of Unani Medicine for Skin Disorders |
| Address |
Room No. 1, GOPD, New Block, NRIUMSD, AGs Colony Road
Hyderabad
TELANGANA
500038
India
Hyderabad
TELANGANA
500038
India |
| Phone |
9848716693 |
| Fax |
|
| Email |
skgulnawaz@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Syed Gunawaz Ahmed |
| Designation |
Research Officer S4 |
| Affiliation |
National Research Institute of Unani Medicine for Skin Disorders |
| Address |
Room no. 1, GOPD, New Block, NRIUMSD, AGs Colony Road
Hyderabad
TELANGANA
500038
India
Hyderabad
TELANGANA
500038
India |
| Phone |
9848716693 |
| Fax |
|
| Email |
skgulnawaz@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ahmed Minhajuddin |
| Designation |
Director |
| Affiliation |
National Research Institute of Unani Medicine for Skin Disorders |
| Address |
Room no.1, GOPD, New Block, NRIUMSD, AGs Colony Road
Hyderabad
TELANGANA
500038
India
Hyderabad
TELANGANA
500038
India |
| Phone |
|
| Fax |
|
| Email |
ahmedminhajuddin@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural support: Nationa Research Institute of Unani Medicine for skin disorders, Hyderabad |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine |
| Address |
61-65, Institutional Area, Opposite "D"Block, Janakpuri, New Delhi- 110058 |
| Type of Sponsor |
Research institution |
|
|
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 SYED GULNAWAZ AHMED |
National Research Institute of Unani Medicine for Skin Disorders |
Room No. 1, GOPD, NEW block, NRIUMSD, Opp: ESI Hospital, Erragadda, Hyderabad
Hyderabad
TELANGANA
Hyderabad
TELANGANA |
9848716693
skgulnawaz@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Research Institute of Unani Medicine for Skin Disorders |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L00-L08||Infections of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Habbe Kibreet Sagheer |
250 mg tablet, twice daily with water for 4 weeks |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. QÅ«bÄ (Dermatophytosis) of < 2 weeks duration
2. Patients with KOH positive
3. lesions having any of the following symptoms:
Presence of pruritus and burning,
Presence of scales,
Presence of central clearing,
Erythematous papules.
|
|
| ExclusionCriteria |
| Details |
1.Co-morbid conditions of the participants
2.Pregnant or Lactating Women
3.Significant Pulmonary/Cardiovascular/Hepato-renal Dysfunction
4.Known cases of Immuno-compromised states (HIV/ AIDS, etc.) Malignancies
• Participants not willing to attend treatment schedule regularly
5.History of hypersensitivity to clotrimazole
6.Participants using the following medications:
7.Systemic antifungal within 15 days of baseline visit.
8.Systemic corticosteroids within 15 days of baseline visit.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the safety of Unani Pharmacopoeial formulation Habbe-kibreet Sagheer in cases of QÅ«bÄ (Dermatophytosis). |
1st week , 4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • To assess the efficacy of Unani Pharmacopoeial formulation Habbe-kibreet Sagheer in cases of QÅ«bÄ (Dermatophytosis). |
1st, 2nd, 3rd, 4th week |
|
|
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 |
|
Date of First Enrollment (India)
|
17/04/2023 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Participants attending the GOPD of National Research Institute of Unani Medicine for Skin Disorders, Hyderabad will be evaluated for presence of QÅ«bÄ. The participants will be assessed for clinical and laboratory parameters. If, they do not meet the exclusion criteria and fulfil the inclusion criteria, they will be enrolled in the present study. They will be informed about the nature and objectives of the study, and details of other study related procedures. Written and signed informed consent form will be obtained from the participants before enrolling them into the study. A detailed clinical history will be recorded and complete physical examination will be carried out to record the various signs and symptoms of QÅ«bÄ. Blood samples will be collected for pathological and biochemical investigations. Study drug will be dispensed as per schedule and participants will be instructed to take the medicine as per the protocol. i.e. Habbe Kibreet Sagheer- one pill of 250 mg to be taken twice daily orally with water for 4 weeks.
|