Study of Marham Kharish Jadeed (Unani Drug) in Ringworm

Phase 2

Completed

Conditions: QUBA (TINEA CORPORIS)

Registration Number: CTRI/2017/12/010995

Lead Sponsor: Central Research Institute of Unani Medicine

Brief Summary: 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, Dafiâ€™-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*, A*rad-i Baqla*, A*rad-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**â€œ**A Clinical Study to Evaluate the Efficacy and Safety of *Marham Kharish Jadeed* in the Management of *Quba* (Tinea Corporis) has been designed.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 60

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.To evaluate the efficacy of Marham Kharish Jadeed in the management of Quba (Tinea corporis)	at baseline 2 3 & 4 week
2.To evaluate the safety of Marham Kharish Jadeed in the management of Quba (Tinea corporis)	at baseline 2 3 & 4 week

Secondary Outcome Measures

Name	Time	Method
To compare the improvement in quality of life in patients with Quba by TSSS KOH mount, IGA	at baseline 2 3 & 4 week

Trial Locations

Locations (1): Central Research Institute of Unani Medicine
🇮🇳
Hyderabad, ANDHRA PRADESH, India
Central Research Institute of Unani Medicine
🇮🇳Hyderabad, ANDHRA PRADESH, India
AALIYA
Principal investigator
9582856055
aaliya.ansari974@gmail.com