| CTRI Number |
CTRI/2024/08/072206 [Registered on: 09/08/2024] Trial Registered Prospectively |
| Last Modified On: |
30/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To evaluate the effect of leech therapy and ointment in the management of ringworm |
|
Scientific Title of Study
|
A Comparative Clinical Study To Evaluate the Efficacy of Irsal-E-Alaq (Leech Therapy) And Marham-E-Quba in the Management of Quba (Dermatophytosis) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Junaid Tahseen |
| Designation |
PG scholar |
| Affiliation |
State unani medical college and hospital, Himmatganj,Prayagraj, Uttar pradesh (211016) |
| Address |
Department of Ilaj-Bit-Tadbeer (IBT), State unani medical college and hospital, Himmatganj
Allahabad
UTTAR PRADESH
211016
India |
| Phone |
8755886869 |
| Fax |
|
| Email |
ansarijunaid56789@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Jamal Akhtar |
| Designation |
Professor |
| Affiliation |
State Unani Medical College, Prayagraj |
| Address |
Department of Ilaj-Bit-Tadbeer (IBT), State Unani Medical College and Hospital, Himmatganj
Allahabad
UTTAR PRADESH
211016
India |
| Phone |
8052142175 |
| Fax |
|
| Email |
drjamalakhtar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Junaid Taseen |
| Designation |
PG Scholar |
| Affiliation |
State Unani Medical College, Prayagraj |
| Address |
Department of Ilaj-Bit-Tadbeer (IBT), State Unani Medical College and Hospital, Himmatganj
Allahabad
UTTAR PRADESH
211016
India |
| Phone |
8755886869 |
| Fax |
|
| Email |
ansarijunaid56789@gmail.com |
|
|
Source of Monetary or Material Support
|
| State unani medical college prayagraj, ministry of AYUSH, U.P. govt |
|
|
Primary Sponsor
|
| Name |
State unani medical college and hospital |
| Address |
Department of Ilaj-Bit-Tadbeer (IBT), State unani medical college and hospital, Himmatganj,Prayagraj, Uttar pradesh (211016) |
| 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 Junaid Tahseen |
State Unani Medical College |
Department of Ilaj-Bit-Tadbeer (IBT), Room no. 2, Ground floor
Allahabad
UTTAR PRADESH |
8755886869
ansarijunaid56789@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 |
| Intervention |
Leech therapy |
No. of leech will be applied on the basis of affected area. One or more leech will be applied on each affected area.Duration variable because its depend upon the sucking power of leech. When leech become fully satisfied with its food, it leaves off the skin of the patient & drops itself down. Leech usually detach after 30 to 60 minutes of its application. In the study, five sitting of leech therapy will be applied with the interval of one week and follow up on 0, 7th, 14th, 21st, 28th days. |
| Comparator Agent |
Marham-e-quba |
Marham-e-Quba will be applied locally on affected area twice a day for 28 days. follow up on 0, 7th, 14th, 21st, 28th days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Clinically Diagnosed patients of Quba on the basis of signs & symptoms and positive KOH examination.
2. Age group 18-60 years.
3. Patients of both genders.
4. Patients not taking any other drugs for Quba.
5. No apparent pathology of the skin.
6. Patients who are willing to sign informed consent.
7. Patient who would be agree to sign the informed consent and follow the protocol. |
|
| ExclusionCriteria |
| Details |
1. Patients below the age of 18 years and above the age of 60 years.
2. Pregnant and lactating women.
3. Known case of bleeding disorder and anaemia.
4. Known case of acute infection and septicaemia.
5. Known cases of severe concomitant skin disease like- Psoriasis, Eczema, impetigo, erysipelas, pityriasis rosea etc.
6. Patient on immuno-compromised drugs.
7. Known cases of severe systemic & metabolic diseases like- Diabetes Mellitus, Hypertension, Hepatitis B, Hepatitis C, and HIV.
8. Any allergy positive patient will be excluded.
9. Non-compliance with the study protocol.
10. Obese patient.
11. Patients who do not want to give their consent for study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Pruritus
2.Erythema
3.Size of lesion
4.Number of lesion
5.Scaling |
0, 7, 14, 21, 28 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.KOH mount
2.Dermatology
Life Quality Index |
0, 28 days |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
15/08/2024 |
| 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="6"
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
|
Quba is also known as dermatophytosis, tinea or ringworm. It is one of the commonest and oldest skin disease. Dermatophytosis is a fungal infection that is characterized by the infection of keratinized tissue such as epidermis, hair and nails caused by a group of closely related filamentous fungi called dermatophytes. Dermatophytosis usually present with typical annular or arcuate or polycyclic lesion which spread centrifugally. margin is active showing papulovesicles, pustule and scaling but center is relatively clear. it is associated with itching, scaling, dryness sometimes fish like scaly lesion shed off from skin. Dermatophytosis is a curable fungal disease. it is usually treated by antifungal topical agents and oral medications, but there are certain limitations that need to be addressed like costly medications, long term therapy, recurrence of the disease, drug resistant and severe side effects of antifungal drugs. In unani system of medicine, many topicals and systemic drugs are being used to treat this disease. similarly most of the unani scholars have recommended various regimenal therapies, which are quite effective to treat quba. these therapies are Irsal-e-alaq (leech therapy), fasd (venesection), hijama-bil-shurt (wet cupping), zimaad (paste), marham (ointment), tila (liniment). |