CTRI Number |
CTRI/2017/12/010995 [Registered on: 27/12/2017] Trial Registered Prospectively |
Last Modified On: |
23/08/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Unani |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Study of Marham Kharish Jadeed (Unani Drug) in Ringworm |
Scientific Title of Study
|
A Clinical Study to Evaluate the Efficacy and Safety of Marham Kharish Jadeed in the Management of Quba (Tinea Corporis) |
Trial Acronym |
TMKJ |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Aaliya |
Designation |
PG Scholar |
Affiliation |
Central Research Institute of Unani Medicine, Hyderabad |
Address |
Deptt. of Moalajat, Central Research Institute of Unani Medicine, Opp. ESI Hospital, AG Colony Road, Erragadda, Hyderabad, Telangana, 500038
Hyderabad ANDHRA PRADESH 500038 India |
Phone |
9582856055 |
Fax |
|
Email |
aaliya.ansari974@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Prof Qamar Uddin |
Designation |
Professor & HOD Moalajat |
Affiliation |
Central Research Institute of Unani Medicine, Hyderabad |
Address |
Deptt. of Moalajat, Central Research Institute of Unani Medicine, Opp. ESI Hospital, AG Colony Road, Erragadda, Hyderabad, Telangana, 500038
Hyderabad ANDHRA PRADESH 500038 India |
Phone |
8700027178 |
Fax |
|
Email |
ccrumhqrsnd58@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Arzeena Jabeen |
Designation |
Lecturer |
Affiliation |
Central Research Institute of Unani Medicine, Hyderabad |
Address |
Deptt. of Moalajat, Central Research Institute of Unani Medicine, Opp. ESI Hospital, AG Colony Road, Erragadda, Hyderabad, Telangana, 500038
Hyderabad ANDHRA PRADESH 500038 India |
Phone |
9032519286 |
Fax |
|
Email |
aarzu763@gmail.com |
|
Source of Monetary or Material Support
|
Central Council for Research in Unani Medicine, MInistry of AYUSH |
|
Primary Sponsor
|
Name |
Central Research Institute of Unani Medicine |
Address |
Opp. ESI Hospital, AG Colony Road, Erragadda, Hyderabad, Telangana, 500038 |
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 |
AALIYA |
Central Research Institute of Unani Medicine |
GOPD No. 3 New OPD block, CRIUM, Opp. ESI Hospital, AG Colony Road, Erragadda, Hyderabad, Telangana, 500038 Hyderabad ANDHRA PRADESH |
9582856055
aaliya.ansari974@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee CRIUM Hyderabad |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
QUBA (TINEA CORPORIS), |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Marham Kharish Jadeed |
Marham will be applied locally on the affected parts twice daily.
Duration: 28 days |
Comparator Agent |
Terbinafine Hydrochloride cream 1% |
Cream will be applied locally on the affected parts twice daily.
Duration 28 days |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
1.Patients having Quba (Tinea corporis) with the following signs and symptom:
a.Itching
b.Erythema
c.Scaling of lesion
d.Central clearing with peripheral raised margins
2.Patients with a mycological diagnosis of Tinea Corporis confirmed by microscopic KOH wet mount |
|
ExclusionCriteria |
Details |
1.All other clinical types of tinea infections
2.Patients with secondary bacterial infections/ Diabetes Mellitus
3.Pregnant and lactating women
4.Significant Pulmonary/Cardiovascular/Hepato-renal Dysfunction
5.Known cases of Immunocompromised states (HIV/ AIDS, etc.)
6.History of hypersensitivity to Terbinafine and Marham Kharish Jadeed
7.Patients using the following medications:
8.Topical antifungal agent/ topical corticosteroids in treatment area within 30 days of baseline visit
9.Systemic anti-fungals within 8 weeks of baseline visit (8 months for oral Terbinafine)
10.Systemic corticosteroids within 30 days of baseline visit
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
1.To evaluate the efficacy of Marham Kharish Jadeed in the management of Quba (Tinea corporis)
2.To evaluate the safety of Marham Kharish Jadeed in the management of Quba (Tinea corporis) |
at baseline 2 3 & 4 week |
|
Secondary Outcome
|
Outcome |
TimePoints |
To compare the improvement in quality of life in patients with Quba by TSSS KOH mount, IGA |
at baseline 2 3 & 4 week |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
Phase of Trial
|
Phase 2 |
Date of First Enrollment (India)
|
01/02/2018 |
Date of Study Completion (India) |
Date Missing |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
None yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Dermatophytic infections are a common clinical problem encountered in more than 50% of participants attending the dermatology departments. According to WHO, about 25% of the world population is affected by dermatophytic infections. It is also estimated that 30 to 70% of adults are asymptomatic carriers of these pathogens, and that the incidence of this disease increases with age. The estimated life-time risk of acquiring dermatophytosis is between 10 to 20 percent. It is caused by Trichophyton, Microsporum, and Epidermophyton which may infect hair, scalp, arms, legs, trunk, groin, and nails. Among various subtypes of dermatophytoses, tinea corporis is a very common skin infection which refers to the dermatophytic infection involving trunk, legs, arms, and neck excluding feet, hands, and groin. The trunk is the most common site. The lesions are itchy, erythematous and scaly patches with well-defined borders. The borders are more prominent and often have papules and pustules. There may be central clearing so that annular or circinate patterns are formed. As the lesion progresses, the border advances centrifugally. The major risk factors of tinea corporis are overcrowding, poor hygiene, and low standards of living along with high humidity. Hence, tinea corporis is more prevalent in tropical and subtropical areas of the world, especially in India. In conventional medicine, certain antifungal drugs such as terbinafine, fluconazole, itraconazole, ketoconazole, griseofulvin, and cotrimazole are used in the management of dermatophytosis with various degrees of resistance and certain side effects such as erythema, itching, dryness, irritation and urticaria etc. Hence, there is a dire need to search for a safe and effective drug for the management of tinea corporis. In Unani System of medicine, Quba is characterized by rough and hyperpigmented patch associated with intense itching but devoid of pain. It has been treated by eminent Unani physicians since antiquity. There are so many topical formulations being used in Quba, i.e., Marham Kharish Jadeed, Marham-i Quba, Habb-i Quba etc. Moreover, drugs possessing Mubarrid, Dafi’-i Ufunat, Mujaffif, Muhallil, and Musaffi-i Dam actions are used in management of Quba such as Gandhak, Sang-i Jarahat, Barg-i-Hina, Kamila, Arad-i Baqla, Arad-i Nakhud, etc. Among these compound formulations, Marham Kharish Jadeed has been extensively used for the management of tinea corporis due to presence of above mentioned properties, but till date its efficacy has not been evaluated on scientific parameters. Hence, in order to validate its efficacy in the management of Quba (Tinea corporis), the present clinical trial entitled “A Clinical Study to Evaluate the Efficacy and Safety of Marham Kharish Jadeed in the Management of Quba (Tinea Corporis) has been designed. |