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CTRI Number  CTRI/2020/04/024765 [Registered on: 21/04/2020] Trial Registered Prospectively
Last Modified On: 11/04/2020
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   A clinical study to evaluate effectiveness of Unani formulations in Tinea 
Scientific Title of Study   A RANDOMIZED, PARALLEL GROUP, OPEN LABEL, STANDARD CONTROLLED CLINICAL STUDY TO COMPARE THE EFFICACY AND SAFETY OF UNANI FORMULATIONS- QURS-E- ASFAR(O) AND ROGHAN-I-NARJIL(L) WITH ITRACONAZOLE(O) AND TERBINAFINE(L) IN THE MANAGEMENT OF QŪBÄ€(DERMATOPHYTOSIS) 
Trial Acronym  PGDT 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Saima Naseem 
Designation  PG Scholar 
Affiliation  National Research Institute of Unani Medicine for Skin Disorders 
Address  Department of Moalajat (Medicine), National Research Institute of Unani Medicine for Skin Disorders, AGs colony road, opp. ESI Hospital, Erragadda

Hyderabad
TELANGANA
500038
India 
Phone  7906027629  
Fax    
Email  saimanaseemazmi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Mohammad Nawab 
Designation  Reader 
Affiliation  National Research Institute of Unani Medicine for Skin Disorders 
Address  Department of Moalajat (Medicine),National Research Institute of Unani Medicine for Skin Disorders, AGs colony road, opp. ESI Hospital, Erragadda

Hyderabad
TELANGANA
500038
India 
Phone  8100992044  
Fax    
Email  ccrumnawab@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Mohammad Nawab 
Designation  Reader 
Affiliation  National Research Institute of Unani Medicine for Skin Disorders 
Address  Department of Moalajat (Medicine),National Research Institute of Unani Medicine for Skin Disorders, AGs colony road, opp. ESI Hospital, Erragadda

Hyderabad
TELANGANA
500038
India 
Phone  8100992044  
Fax    
Email  ccrumnawab@gmail.com  
 
Source of Monetary or Material Support  
National Research Institute of Unani Medicine for Skin Disorders, Opp. ESI Hospital, AG Colony Road, Erragadda, Hyderabad, 500038 
 
Primary Sponsor  
Name  National Research Institute of Unani Medicine for Skin Disorders 
Address  Opp. ESI Hospital, AG Colony Road, Erragadda, Hyderabad, 500038 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Saima Naseem  National Research Institute Of Unani Medicine for Skin Disorders  Moalajat OPD No. 1, Dept. of Moalajat, New OPD Block, NRIUMSD,AG Colony Road, Opp. ESI Hospital, Erragadda
Hyderabad
TELANGANA 
7906027629

saimanaseemazmi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, NRIUMSD, Hyderabad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L089||Local infection of the skin and subcutaneous tissue, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group A: Study Group (Unani Drug Group)  Qurs-i-Asfar (oral) Roghan-i-Narjil (local) Method of Preparation- The drug will be prepared in single batch on the guidelines and method of preparation described in the National Formulary of Unani Medicine Part-4 and 5 in GMP certified pharmacy of NRIUMSD, Hyderabad. Dose & Route of Administration: Qurs-i-Asfar:1 tablet(775mg) each used twice a day Roghan-i-Narjil:Oil will be applied locally on the affected parts thrice daily. Duration of therapy:6 weeks  
Comparator Agent  Group B: Active Control Group Itraconazole (oral) Terbinafine cream 1%(local)   Itraconazole (oral) Terbinafine cream 1% (local) Dosage: Itraconazole (O)-100 mg BD Terbinafine (L)- application on affected parts twice daily 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  The participants will be included in the study on the basis of the following criteria:
1.Circumscribed lesions having any of the following signs and symptoms on body and limbs:
Presence of pruritus and burning,
Presence of scales,
Presence of central clearing,
Erythematous papules.
2.Participants with positive mycology (KOH positive).
3.Participants of either sex in age group of 18-60 years

 
 
ExclusionCriteria 
Details  The following participants will be excluded:
1.Co-morbid conditions of the participants
2.Pregnant or Lactating Women
3.Significant Pulmonary/Cardiovascular/Hepato-renal Dysfunction
4.Known cases of Immuno-compromised states (HIV/ AIDS, etc.)/ Malignancies
5.Participants not willing to attend treatment schedule regularly
6.History of hypersensitivity to Itraconazole and Terbinafine.
7.Participants using the following medications:
Systemic antifungal within 15 days of baseline visit.
Systemic corticosteroids within 15 days of baseline visit.
 
 
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.Total Signs and Symptoms Score(TSSS): The efficacy of the test drug will be assessed on the basis of clinical signs and symptoms on each follow-up, which will be rated on point scale.

2.Conversion to Negative Mycology: The conversion of the treated lesions from positive mycology (KOH positive mount) at the base line to negative mycology (KOH negative mount) at the end of trial.
 
At baseline, 2nd, 3rd and 4th followups
 
 
Secondary Outcome  
Outcome  TimePoints 
Haemogram, Urine: RE & ME, LFT, KFT, FPG  At baseline and end of the trial 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   01/07/2020 
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   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

QÅ«bā (Dermatophytosis) is a group of fungal infections of keratinized tissues like the epidermis, hair and nails[1]. QÅ«bā (Dermatophytic infection) is one of the commonest and oldest diseases of the skin. This clinical problem is encountered in more than 50% of the patients who were attending to the dermatology departments.[2]  As per WorldHealth Organizations (WHO), the prevalence of superficial fungal infection worldwide has been found to be 20-25% and it is more prevalent in tropical and subtropical countries like India where the heat and humidity is high throughout the year.[3]  The estimated lifetime risk of acquiring Dermatophytosis is between 10-20%.[4]

In South India, Qūbā is more prevalent because of having hot and humid climate which is more favorable for the development of the superficial mycoses.[1]

Qūbā (dermatophyte infection) is extremely common and usually caused by the fungi of the Microsporum, Trichophyton and Epidermophyton species.[5] They produce keratinases which degrade the keratin and thus, invade the superficial skin tissue.[5],[6]The infections due to these pathogens are generally cutaneous and restricted to the non-living, cornified layers of the skin.[6] The fungi can be transmitted through soil known as geophilic or by the animals i.e. zoophilic or it can remain in human skin (anthrophilic).[5]

Qūbā (Dermatophytosis) also have many ill impact on the patient’s quality of life. The lives of the families of patients with Qūbā may be affected. The patient may experience severe symptoms, especially itch, sometimes pain, discomfort and can become profoundly psychologically disturbed. The choice of clothes may be restricted. Social activities such as going out with friends or taking parts in sports, swimming or other physical activities may become difficult, often because of a reluctance to allow others to see the diseased skin what others may think.[7] The itch, appearance may interfere with work and may cause disturbed sleep.

In conventional medicine, certain antifungal drugs like  Terbinafine, Itraconazole, Flucanazole, Ketoconazole, Clotrimazole are used in the management of dermatophytosis with various degrees of resistance and certain side effects such as erythema, itching, dryness, irritation and urticaria, nausea, diarrhea,abdominal pain, headache, rashes, etc.[8]

Hence, because of the more prevalence of this disease and the significant impact on the quality of life and because of the conventional medicine’s side effects, there is a dire need to search for those formulations which are more effective and safe and which can improve the quality of life of the patients.

There are many formulations which are being used in the QÅ«bā like Roghan-i NārjÄ«l,[9][10]Qurá¹£-I Aá¹£far[9], Marham-e-kharishJadeed,[9]Marham-e-QÅ«bā,[9]Habb-e- QÅ«bā,[9]etc. Moreover drugs possessing the properties of MusaffÄ«, Mujaffif, JālÄ«, mudammil-e-Qurūḥ, Musakkin, Daf‘a-e-kharish, Muḥallil, Daf‘-iUfÅ«natare used in the management of the QÅ«bā such as, Gandhak(sulphur)[11],  Sang-iJarāhat(Magnesium silicate)[11], TutiyaSabz(Copper sulphate),[11]Naushadar(Ammonium chloride),[11]Suhaga(Borax),[12]Roghan-ikunjad(Sesamum indicum L),[11]etc.

Although, above mentioned formulations were used by many ancient Unani physicians and still are being used but some of them are not yet scientifically evaluated on modern parameters. . Hence, in order to evaluate efficacy and safety of Qurá¹£-i Aá¹£far[9] and Roghan-i NārjÄ«l[9],[10] in the management of QÅ«bā,the present clinical trial entitled “A Randomized Parallel Group Open Label Standard Controlled Clinical Study to compare the Efficacy and Safety of Unani Formulations – Qurá¹£-i Aá¹£far (O) and Roghan-i NārjÄ«l (L) with Itraconazole (O) and Terbinafine (L) in the Management of QÅ«bā (Dermatophytosis)” has been designed. 
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