| CTRI Number |
CTRI/2021/08/036043 [Registered on: 31/08/2021] Trial Registered Prospectively |
| Last Modified On: |
25/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluating Efficacy of Unani Formulation in Tinea |
|
Scientific Title of Study
|
A Randomized, Parallel Group, Open Label, Standard Controlled Clinical Study to Compare the Efficacy and Safety of Unani Formulation - Roghan-i Zarneekh (T) with Luliconazole (T) in the Management of QÅ«bÄ (Dermatophytosis) |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kamal Ahmad |
| Designation |
PG Scholar |
| Affiliation |
National Research Institute of Unani Medicine for Skin Disorders |
| Address |
Deparment of Moalajat, National Research Institute of Unani Medicine for Skin Disorders, A G Colony Road, Erragadda, Hyderabad, Telangana 500038
Hyderabad
TELANGANA
500038
India |
| Phone |
8006363813 |
| Fax |
|
| Email |
kamalahmad788@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arzeena Jabeen |
| Designation |
Lecturer |
| Affiliation |
National Research Institute of Unani Medicine for Skin Disorders |
| Address |
Deparment of Moalajat, National Research Institute of Unani Medicine for Skin Disorders, A G Colony Road, Erragadda, Hyderabad, Telangana 500038
Hyderabad
TELANGANA
500038
India |
| Phone |
9032519286 |
| Fax |
|
| Email |
aarzu763@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arzeena Jabeen |
| Designation |
Lecturer |
| Affiliation |
National Research Institute of Unani Medicine for Skin Disorders |
| Address |
Deparment of Moalajat, National Research Institute of Unani Medicine for Skin Disorders, A G Colony Road, Erragadda, Hyderabad, Telangana 500038
Hyderabad
TELANGANA
500038
India |
| Phone |
9032519286 |
| Fax |
|
| Email |
aarzu763@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, Erragadda, Hyderabad, Telangana 500038 |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Kamal Ahmad |
National Research Institute of Unani Medicine for Skin Disorders |
OPD of Dept of Moalajat, New OPD Block, National Research Institute of Unani Medicine for Skin Disorders, AG Colony Rd, Erragadda, Hyderabad, Telangana 500038
Hyderabad
TELANGANA |
8006363813
kamalahmad788@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, NRIUMSD, Hyderabad |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L089||Local infection of the skin and subcutaneous tissue, unspecified, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Luliconazole cream 1% (T) |
Method of Application : cream will be applied topically on the affected parts once daily
Duration of therapy: 4 weeks |
| Intervention |
Roghan-i Zarneekh (T) |
Oil will be applied topically on the affected parts twice daily
Duration of therapy: 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
The partcipants will be included in the study on the basis of the following criteria:
i. Participants with positive mycology (KOH positive)
ii. Circumscribed lesions having any of the
following signs and symptoms on trunk and inguinal region:
a. Presence of pruritus and burning
b. Presence of scales
c. Presence of central clearing
d. Erythematous papules |
|
| ExclusionCriteria |
| Details |
The partcipants will be excluded:
i. Co-morbid conditions of the participants
ii. Pregnant or Lactating Women
iii. Significant pulmonary/ cardiovascular/ hepatorenal dysfunction
iv. Known cases of Immuno-compromised states (HIV/ AIDS, etc.), malignancies
v. History of Hypersensitivity to Luliconazole
vi. Participants not willing to attend treatment schedule regularly
vii. Participants using the following medications:
a. Systemic antifungal within 15 days of baseline visit
b. Systemic corticosteroids within 15 days of baseline visit |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
1.Total Signs and Symptoms Score (TSSS):The efficacy of the test drug will be assessed on the basis of clinical signs and symptoms on each follow-up, which will be rated on four-point scale.
2.Conversion to Negative Mycology:
The conversion of the treated lesions from positive mycology (KOH positive mount) at the baseline to negative mycology (KOH negative mount) at the end of treatment.
|
At baseline, 1st, 2nd, 3rd, 4th followups.
|
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Hemogram, Urine: RE & ME, LFT, KFT, FPG. |
At baseline and end of the trial. |
|
|
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)
|
01/09/2021 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
yet to be published |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Title of the Study: A Randomized, Parallel Group, Open Label, Standard Controlled Clinical Study to Compare the Efficacy and Safety of Unani Formulation - Roghan-i Zarneekh (T) with Luliconazole (T) in the Management of QÅ«bÄ (Dermatophytosis) Objectives of the Study: To evaluate the efficacy of Roghan-i Zarneekh (T) as compared to an allopathic drug in the management of QÅ«bÄ (Dermatophytosis)
To evaluate the safety of Roghan-i Zarneekh (T) as compared to an allopathic drug in the management of QÅ«bÄ (Dermatophytosis)
Study Rationale (justification for conduct of this study)
The prevalence of QÅ«bÄ (Dermatophytosis) is 20- 25% worldwide. It also has many ill impacts on the patient’s quality of life. In conventional medicine, some antifungal drugs are used in the treatment of dermatophytosis, which are becoming resistant to the organism and also have certain adverse effects as headache, nausea, vomiting, abdominal pain, rashes, hepatotoxicity, hypokalaemia, oligozoospermia, etc. Hence, there is need to search drugs which may be effective and safe in the management of QÅ«bÄ (Dermatophytosis). Keeping this in view, a Unani formulation Roghan-i-Zarneekh has been selected to evaluate its efficacy and safety in the management of QÅ«bÄ (Dermatophytosis).
Study Design: Randomized, Standard Controlled, Parallel Group, Open Label Clinical Study Inclusion Criteria i. Participants of either sex in age group of 18-60 years ii. Participants with positive mycology (KOH positive) iii. Circumscribed lesions having any of the following signs and symptoms on trunk and inguinal region: a. Presence of pruritus and burning b. Presence of scales c. Presence of central clearing d. Erythematous papules
Exclusion Criteria i. Co-morbid conditions of the participants ii. Pregnant or Lactating Women iii. Significant pulmonary/ cardiovascular/ hepatorenal dysfunction iv. Known cases of Immuno-compromised states (HIV/ AIDS, etc.), malignancies v. History of Hypersensitivity to Luliconazole vi. Participants not willing to attend treatment schedule regularly vii. Participants using the following medications: a. Systemic antifungal within 15 days of baseline visit b. Systemic corticosteroids within 15 days of baseline visit
Sample Size 60 (Test Group = 30 & Control Group = 30)
Test Drug Roghan-i Zarneekh Local application Control Drug Luliconazole cream 1% Local application
Duration of Treatment: 4 weeks
Investigations to be done ï‚· Haemogram: Hb, TLC, DLC, ESR ï‚· Urine: RE & ME ï‚· LFTs: SGOT, SGPT, S. Alkaline Phosphatase, S. Bilirubin ï‚· KFTs: S. Creatinine and BUN ï‚· Fasting Plasma Glucose (FPG) ï‚· KOH Examination .
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