| CTRI Number |
CTRI/2023/06/053844 [Registered on: 14/06/2023] Trial Registered Prospectively |
| Last Modified On: |
13/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Research on Ringworm in Unani Medicine |
|
Scientific Title of Study
|
A Comparative Study on the Efficacies of Joshanda Haleela Siyah with topical zimads in Qooba (Tinea Corporis )-A Randomized Single Blind 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 |
Dr Sana Hasan |
| Designation |
PG Scholar ,Amraze Jild Wa Tazeeniyat |
| Affiliation |
National Institute Of Unani Medicine |
| Address |
Department of Amraze jild wa tazeeniyat ,2nd Floor National Institute Of Unani Medicine Magadi Main Road Kottigepalya Bengaluru -560091
Department of Amraze Jild Wa Tazeeniyat, 2nd Floor National Institute Of Unani Medicine Magadi Main Road Kottigepalya Bengaluru-560091
Bangalore
KARNATAKA
560091
India |
| Phone |
9129794978 |
| Fax |
|
| Email |
stillarsana@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Iram Naaz |
| Designation |
Assistant Professor, Amraze Jild wa Tazeeniyat |
| Affiliation |
National Institute Of Unani Medicine |
| Address |
National Institute Of Unani Medicine Magadi Road Kottigepalya Bengaluru- 560091
National Institute Of Unani Medicine Magadi Road Kottigepalya Bengaluru- 560091
Bangalore
KARNATAKA
560091
India |
| Phone |
9916233452 |
| Fax |
|
| Email |
iramnaaz144@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Mohd Aleemuddin Quamri |
| Designation |
Head Of Department, Amraze Jild wa Tazeeniyat |
| Affiliation |
National Institute Of Unani Medicine |
| Address |
National Institute Of Unani Medicine Magadi Road Kottigepalya Bengaluru- 560091
National Institute Of Unani Medicine Magadi Road Kottigepalya Bengaluru- 560091
Bangalore
KARNATAKA
560091
India |
| Phone |
9341072974 |
| Fax |
|
| Email |
drmaquamri@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Unani Medicine , Bengaluru |
|
|
Primary Sponsor
|
| Name |
National Institute of Unani Medicine |
| Address |
National Institute of unani Medicine ,Magadi Main Road , Kottigepalya ,Bengaluru ,Karnataka |
| Type of Sponsor |
Government medical college |
|
|
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 Sana Hasan |
National Institute Of Unani Medicine |
OPD room no 4 and IPD
Amraze jild wa Tazeeniyat Department
Bangalore
KARNATAKA |
9129794978
stillarsana@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Biomedical Research |
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 |
| Comparator Agent |
Oral : Joshanda Haleela Siyah
Topical: Tukhm e Turb and Sirka
|
In the patients of group B, Joshanda Haleela Siyah is administered orally empty stomach in the morning before a meal and then the patient has to wash the affected area with lukewarm water and pat dry then apply the zimad of Tukhm Turb and Sirka on the affected area and leave it for 20 minutes and then wash.(Total Duration :3 Weeks) |
| Intervention |
Oral :Joshanda Haleela Siyah
Topical : Zimad of Tukhm e Panwad , Kunjad Siyah , Sarshaf |
In the patients of group A, Joshanda Haleela Siyah is administered orally empty stomach in the morning before a meal and then the patient has to wash the affected area with lukewarm water and pat dry then apply the zimad of Tukhm Panwad, Kunjad Siyah and Sarshaf on the affected area and leave it for 20 minutes and then wash.(total duration :3 weeks ) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Clinically diagnosed cases of Tinea Corporis with less than or equal to 3% body surface area (calculated by the palm rule)Patients whose KOH is positive.
2. Patient of either gender.
3. Age group 18-60 years.
4).Patient with controlled diabetes |
|
| ExclusionCriteria |
| Details |
1.Known cases of tinea corporis on medication one month prior
2. Patients of T. Corporis with more than 3% body surface area.
3. Patients whose KOH is negative.
4. Patients below and above the age of 18 and 60 years respectively.
5. Patients suffering from concomitant skin diseases like psoriasis & Eczema and other types of tinea like T. Cruris, T. Facei, T.Capitis, T.Unguum, T.Manuum.
6. Pregnant & Lactating Women.
7. Known history of impaired hepatic, renal or cardiovascular functions in patients.
8. Uncontrolled cases of Diabetes and other immunocompromised patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary End Points:
complete clearance among groups at the end of the intervention
Secondary End Points:
a) Comparison of achieved clinical cure among groups at the end of the intervention
|
3 Weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary End Points:
a) Comparison of achieved clinical cure among groups at the end of the intervention
b) Comparison of achieved Mycological cure among groups at the end of the
intervention |
3 Weeks |
|
|
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)
|
24/06/2023 |
| 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="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)?
Response - NO
|
|
Brief Summary
|
Dermatophytes are known to cause superficial mycosis in animals and humans owing to their ability to destroy keratin present in skin, hair and nails leading to the development of dermatophytosis. One of the dermatophytosis is ringworm (Tinea corporis) infection which is known to affect approximately 20-25% of the global population. These infections are common in the tropics due to high levels of humidity, overpopulation and poor hygiene. The global prevalence of dermatophytosis is estimated to be 20%. The prevalence of dermatophytes has increased tremendously in the last few decades due to various factors like climate change, socio-economic and occupational situations. It has been observed recently that there has been widespread resistance to various antifungal agents used in conventional doses with an increase in relapse rates prompting a need to find effective first-line antifungal drugs and appropriate dosages and drug schedules to achieve maximum results with fewer relapses. The most common side effects of antifungal drugs are gastric upset, headache, altered taste, altered liver function tests and rash, even cause blood dyscrasias and hepatitis. Likewise, long-term use of steroid creams can make ringworm worse by allowing them to spread along making the immune system weak and in some rare cases, it allows the fungus that causes ringworm to invade deeper into the skin and cause the more serious condition. In the Unani system of medicine, several formulations are indicated for the management of tinea corporis(Qooba )and all such formulations are tested for centuries and data on their effectiveness is available. So the present study has been designed to validate the effectiveness of some of the formulations on scientific rationale.
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