| 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 QŪBĀ(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
|
|
|
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
|
|
|
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«bÄ (Dermatophytosis) is a group of fungal infections of keratinized tissues like the epidermis, hair and nails[1]. QÅ«bÄ (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, QÅ«bÄ is more prevalent because of having hot and humid climate which is more favorable for the development of the superficial mycoses.[1] QÅ«bÄ (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] QÅ«bÄ (Dermatophytosis) also have many ill impact on the patient’s quality of life. The lives of the families of patients with QÅ«bÄ 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«bÄ like Roghan-i NÄrjÄ«l,[9][10]Qurá¹£-I Aá¹£far[9], Marham-e-kharishJadeed,[9]Marham-e-QÅ«bÄ,[9]Habb-e- QÅ«bÄ,[9]etc. Moreover drugs possessing the properties of MusaffÄ«, Mujaffif, JÄlÄ«, mudammil-e-Qurūḥ, Musakkin, Daf‘a-e-kharish, Muḥallil, Daf‘-iUfÅ«natare used in the management of the QÅ«bÄ such as, Gandhak(sulphur)[11], Sang-iJarÄhat(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 NÄrjÄ«l[9],[10] in the management of QÅ«bÄ,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 NÄrjÄ«l (L) with Itraconazole (O) and Terbinafine (L) in the Management of QÅ«bÄ (Dermatophytosis)†has been designed. |