| CTRI Number |
CTRI/2019/06/019781 [Registered on: 20/06/2019] Trial Registered Prospectively |
| Last Modified On: |
17/06/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani
Other (Specify) [Unani Regimen (Leech therapy)] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of Leech therapy in Ringworm |
|
Scientific Title of Study
|
Long Term Efficacy evaluation of Irsal-i-Alaq (Leech Therapy) in Qooba (Dermatophytosis)- A Randomised Standard Controlled Open Clinical Study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jamil Ahmad |
| Designation |
PG Scholar |
| Affiliation |
national institute of unani medicine kottigepallya magadi main road, bengaluru |
| Address |
Deptt of IBT, academic building national institute of unani medicine kottigepallya magadi main road, bengaluru
Bangalore
KARNATAKA
560091
India |
| Phone |
9412108238 |
| Fax |
|
| Email |
jamilji2k11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abdul Azeez |
| Designation |
Assistant prof. |
| Affiliation |
national institute of unani medicine kottigepallya magadi main road, bengaluru |
| Address |
Deptt of IBT, academic building national institute of unani medicine kottigepallya magadi main road, bengaluru
Bangalore
KARNATAKA
560091
India |
| Phone |
9035417278 |
| Fax |
|
| Email |
aafaris@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abdul Azeez |
| Designation |
Assistant prof. |
| Affiliation |
national institute of unani medicine kottigepallya magadi main road, bengaluru |
| Address |
Deptt of IBT, academic building national institute of unani medicine kottigepallya magadi main road, bengaluru
KARNATAKA
560091
India |
| Phone |
9035417278 |
| Fax |
|
| Email |
aafaris@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Unani Medicine, Kottigepallya, Magadi Main Road, Bengaluru, 560091, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
National Institute of Unani Medicine |
| Address |
Kottigepallya Magadi Main Road, Bengaluru, 560091, Karnataka, India |
| 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 |
| Jamil Ahmad |
National Institute of Unani Medicine |
Room No. 28, Dept. ILAJ BIT TADBEER, Room No. 04, Dept. AMRAZ-i-JILD of National Institute of Unani Medicine Hospital, Kottigepallya Magadi Main Road, Bengaluru, 560091
Bangalore
KARNATAKA |
9412108238
jamilji2k11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B359||Dermatophytosis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Clotrimazole (1%) cream.
|
control group will apply Clotrimazole (1%) cream twice daily over the affected site continuously for 28 days.
|
| Intervention |
Leech therapy |
Five sittings of leech therapy will be applied, with intervals of one week. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Clinically Diagnosed patient of Qooba (Tinea corporis and Tinea pedis only, as leech application will be more feasible to these sites)
Willing to participate in the study and follow the
instructions
|
|
| ExclusionCriteria |
| Details |
Uncontrolled Diabetes mellitus
Bleeding disorder & anaemia
Acute infection & septicaemia
Patients on concomitant therapy
Immuno-compromised patients
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
KOH smear
Erythema and Scaling will be graded on a 4 point scale (0 Absent, 1 Mild, 2 Moderate and 3 Severe)
Pruritus will be assessed on 10 cm long Visual Analogue Scale (VAS).
Photographs of the affected site in a fixed location and controlled illumination. |
At Baseline, on 21st day and on 35th day.
Follow ups on 35th day in person and over phone on 45th, 60th and 90th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
24/06/2019 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Dermatophytosis
refers to
superficial fungal infection of keratinized tissues caused by keratinophilic
dermatophytes. According to observations worldwide, dermatophytosis is
the most common superficial fungal infections. It is common in tropics and may present
in epidemic proportions in areas with high rates of humidity.
In Unani system of medicine, a disease mentioned
with name of Qooba, is characterized by roughness of the
surface of the skin associated with itching, scaling, dryness, and shedding of
scales like fish.It
may be black or red in colour, usually periphery is red and occasionally there
may be oozing of yellowish fluid. All
these conditions develop according to pathogenic substances, as per Unani
philosophy. Dermatophytosis
is given name according to the sites involved Tinea capitis, Tinea corporis,
Tinea faciei,
Tinea manuum, Tinea pedis, Tinea ungum, Tinea cruris,
Tinea incognito. Treatment
of dermatophytosis
is often dependent on the clinical setting ideally, mycological confirmation of
the clinical diagnosis should be gained before systemic antifungal treatment is
commenced. Oral
treatment options for dermatophytosis
are Itraconazole,
Fluconazole, Terbinafine,
and Griseofulvin. In
Unani
system of medicine there are number of treatments for Qooba,
in which Irsal-i-Alaq
(Leeching) is one of the best treatment described by the Unani
physicians. Irsal-i-Alaq
is used to evacuate the pathological humour from the body to treat the various
ailments. According
to Ahmad bin Muhammad Tabri
Irsal-i-Alaq
over affected site will eliminate the disease completely. Inspired
by all these facts, this study was design to evaluate not only the efficacy but
long-term effects of Irsal-i-Alaq in
Qooba, comparing with
standard antifungal treatment for the same. |