| CTRI Number |
CTRI/2022/03/041124 [Registered on: 15/03/2022] Trial Registered Prospectively |
| Last Modified On: |
21/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Efficiency of unani formulation in ringworm disease |
|
Scientific Title of Study
|
Efficacy of Unani Formulations, Irsale Alaq and Terbinafine, in Quba – A Comparative Randomized Controlled Clinical Trial |
| Trial Acronym |
- |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arisha Shahid |
| Designation |
PhD Research Scholar |
| Affiliation |
National Institute of Unani Medicine |
| Address |
National Institute of Unani Medicine
Kottigepalya Magadi main Road
Bengaluru
Karnataka
Bangalore
KARNATAKA
560091
India |
| Phone |
9972638514 |
| Fax |
|
| Email |
arishashahid0000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof MA Quamri |
| Designation |
Professor and HoD |
| Affiliation |
National Institute of Unani Medicine |
| Address |
National Institute of Unani Medicine
Kottigepalya Magadi main Road
Bengaluru
Karnataka
Bangalore
KARNATAKA
560091
India |
| Phone |
|
| Fax |
|
| Email |
drmaquamri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof MA Quamri |
| Designation |
Professor and HoD |
| Affiliation |
National Institute of Unani Medicine |
| Address |
National Institute of Unani Medicine
Kottigepalya Magadi main Road
Bengaluru
Karnataka
Bangalore
KARNATAKA
560091
India |
| Phone |
|
| Fax |
|
| Email |
drmaquamri@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Unani Medicine |
|
|
Primary Sponsor
|
| Name |
National Institute of Unani Medicine |
| Address |
Kottigepalya Magadi Main Road
Bengaluru |
| 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 Arisha Shahid |
National Institute of Unani Medicine |
D/o Moalajat
National Institute of Unani Medicine
Kottigepalya magadi main Road
Bengaluru
Bangalore
KARNATAKA |
9972638514
arishashahid0000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC NIUM |
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 |
| Intervention |
Irsale Alaq (Leeching) |
Irsale Alaq (Leech Therapy)
Two medicinal leeches per sitting will be applied over the affected area after thoroughly adopting pre surgical procedure with aseptic precautions in 7 sittings with an interval of 5 days each.
|
| Intervention |
Joshanda Aftimoon orally and Tila Ushaq topically |
Joshanda Aftimoon (Cuscuta reflexa Roxb.):
Decoction made up of the powdered Aftimoon simmered in one glass of hot water and filtered will be served for 30 days
TilaUshaq (Dorema ammoniacum D.Don)
Ushaq (Dorema ammoniacum D. Don) powdered mixed with Sirka (Sugarcane Vinegar)to be applied locally on the lesion for 30 days |
| Comparator Agent |
Terbinafine cream 1% |
Terbinafine 1% cream to be Applied over the affected area and 1 inch surrounding that area in a thin layer twice daily for 30 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
 Patients aged 18-60 years of either sex with a clinical diagnosis of Tinea corporis and/or Tinea cruris with ≤ 5% body surface area involvement
 Patients with Global assessment score of ≥ 5 with positive KOH mount
 Patients who will give consent and are able to do follow up
|
|
| ExclusionCriteria |
| Details |
 Immuno-compromised patients
 Patients with extensive Dermatophytosis, other forms of tinea infections, superadded bacterial infection
 Patients with contact dermatitis, atopic dermatitis, psoriasis, other skin diseases
 Patients with a history of hypersensitivity to allylamine antifungals
 Patients who received topical antifungal within 1 week and systemic antifungals within 4 weeks prior to enrolment
 Patients with a known history or clinical evidence of bleeding disorders, severe systemic illness and uncontrolled diabetes mellitus
 Pregnant and lactating females
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of achieved complete clearance among groups at the end of treatment |
Baseline and after treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a. Comparison of achieved clinical cure among groups at the end of treatment
b. Comparison of achieved Mycological cure among groups at the end of treatment
c. Comparison of relapse among groups at the end of treatment
d. Improvement in DLQI
|
before and After study |
|
|
Target Sample Size
|
Total Sample Size="111"
Sample Size from India="111"
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)
|
01/04/2022 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Patients fulfilling
the inclusion criteria will be enrolled after obtaining written informed
consent. They will be randomly allocated into 03 groups (by block randomization
method) viz; Group A, Group B, and Group C (n=37 in each group). Patients
in group A will be given Joshanda Aftimoon (oral) + Tila Ushaq (topical) in the dosage
form as mentioned above. Whereas, patients in Group B
will receive 07 sittings of Leech therapy with the interval of 05 days.
Total 02 leeches will be applied per sitting. Moreover, group C patients will be advised to apply 1% Terbinafine cream over the
affected area and 1 inch surrounding that area in a thin layer twice daily
for 30 days. Baseline clinical parameters such
as erythema, scaling, pruritus, papules will be assessed using 4 point scale by
the investigator. [Score 0=absent, 1=mild, 2=moderate, 3=severe]. Global
assessment score will be calculated on each follow-up visit by summation of
scores on all four parameters in a patient30,31,32,33. Patients will be instructed to come for the
KOH mount after taking bath with unscented soap and water and without applying
any cream or ointment. They will also be advised to clean and dry the affected area before applying medication. Tablet
Atarax (Hydroxyzine) 10 mg single doses will be provided as rescue medication
if required. Follow-up will be done on 15th
day for assessment of clinical cure, on 30th day for the clinical and mycological
cure and after 45th day for potential relapse. Photographs of the lesion will be taken for evidence of improvement. The
investigations will be done before and after the completion of the trial. The pre and post-treatment objective findings (effects) will be assessed
statistically. |