| CTRI Number |
CTRI/2020/06/026209 [Registered on: 29/06/2020] Trial Registered Prospectively |
| Last Modified On: |
26/06/2020 |
| 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 assess Effectiveness of Unani formulations in pityriasis versicolor |
|
Scientific Title of Study
|
A Randomized, Parallel Group, Open Label, Standard Controlled Clinical Study to Evaluate Efficacy and Safety of Unani Formulations (Oral and Topical) in Management of Bahaq (Pityriasis Versicolor) |
| Trial Acronym |
RCTPV |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abdullah Ismail Bhoraniya |
| Designation |
Research Scholar |
| Affiliation |
KALOJI NARAYANA RAO UNIVERSITY OF HEALTH SCIENCES,WARANGAL (KNRUHS) |
| Address |
National Research Institute of Unani Medicine for Skin Disorders, AG Colony Road, Opp. ESI Hospital, Erragadda, Hyderabad-500 038
Hyderabad
TELANGANA
500038
India |
| Phone |
9819921014 |
| Fax |
|
| Email |
abdullahismail519@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohammad Nawab |
| Designation |
Reader |
| Affiliation |
National Research Institute of Unani Medicine for Skin Disorders, Hyderabad |
| Address |
National Research Institute of Unani Medicine for Skin Disorders, AG Colony Road, Opp. ESI Hospital, Erragadda, Hyderabad-500 038
Hyderabad
TELANGANA
500038
India |
| Phone |
8100992044 |
| Fax |
|
| Email |
ccrumnawab@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Qamar Uddin |
| Designation |
Professor |
| Affiliation |
National Research Institute of Unani Medicine for Skin Disorders, Hyderabad |
| Address |
National Research Institute of Unani Medicine for Skin Disorders, AG Colony Road, Opp. ESI Hospital, Erragadda, Hyderabad-500 038
Hyderabad
TELANGANA
500038
India |
| Phone |
8700027178 |
| Fax |
|
| Email |
ccrumhqrsnd58@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Research Institute of Unani Medicine for Skin Disorders, AG Colony Road, Opp. ESI Hospital, Erragadda, Hyderabad-500 038 |
|
|
Primary Sponsor
|
| Name |
National Research Institute of Unani Medicine for Skin Disorders Hyderabad |
| Address |
National Research Institute of Unani Medicine for Skin Disorders, AG Colony Road, Opp. ESI Hospital, Erragadda, Hyderabad-500 038 |
| 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 |
| Abdullah Ismail Bhoraniya |
National Research Institute of Unani Medicine for Skin Disorders NRIUM-SD, Hyderabad |
IPD and general OPD, department of moalajat
Hyderabad
TELANGANA |
9819921014
abdullahismail519@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics commitee |
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 |
Itraconazole (100 mg) and Terbinafine 1% cream |
Itraconazole (100 mg) orally once daily and they will also advised to apply Terbinafine 1% cream locally on the affected part twice daily for 42 days. |
| Intervention |
Itrifal Hakim Ali (Oral) and Habb-e- Kalaf (topical, mix the pills in Aab-e-Lemu) |
Itrifal Hakim Ali in the dose of 10gm once daily and they will also be advised to apply Habb-e- Kalaf locally (mix the pills in Aab-e- Lemu)on the affected part twice daily for 42 days |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants of any sex aged 19-60 years
Participant having any of the sign and symptoms of Bahaq
Hypopigmented macule
Hyperpigmented macule
Erythema
Pruritus on the lesion
Scaling / Desquamation and
Presence of Malassezia furfurin the scrapings of the lesion
|
|
| ExclusionCriteria |
| Details |
Participant with serious co-morbid medical condition and other fungal infection
Participant who had received any systemic or topical antimycotic therapy within month of start of study
Pregnant or Lactating Women
Significant Pulmonary/Cardiovascular/Hepato-renal Dysfunction
Known cases of Immunocompromised states (HIV/ AIDS, etc.)/ Malignancies
Participant not willing to attend treatment schedule regularly
|
|
|
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 |
Assessment of Response to Therapy: Clinical assessment will be done at 0,2, 4, 6weeks and the response to treatment will be assessed using the following parameters:
1.Total sign and symptoms score (TSSS)
2.Investigator Global assessment
3.KOH examination:
4. Fungus Culture: if possible in 5 participants’
|
outcomes will be assessed at baseline,2 weeks, 4 weeks and at 6 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Lab investigation |
0 and 6 weeks |
|
|
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
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Pityriasis versicolor (Tinea versicolor or PV) is a superficial fungal infection, characterized by changes in skin pigment due to colonization of stratum corneum by a dimorphic lipophilic fungus of the normal flora of the skin, known as Malassezia furfur . It mostly occurs in young adult, less common when sebum production is reduced or absent; tapper off during 5th and 6th decades of life . In 90% adult Malassezia is commonly found in seborrheic areas and become pathogenic in warm and Humid environment . Its incidence in temperate zone is 2% and in tropical zones 40% . Despite the effective therapeutic regimes available in conventional system of medicine it often possesses a therapeutic challenge . Morbidity results primarily from the discoloration. The adverse cosmetic effect of lesion may lead to significant emotional distress, particularly in adolescents . Despite adequate therapy it frequently recurs and residual pigmentary changes may take several weeks to resolve . Topical drug provides immediate reductions in infectivity but have some disadvantages such as the time needed for therapy, difficult application of the drug over large area of disease, for these reason patient adhesions is inadequate which increase the rate of recurrence. It has impact on patient quality of life. Drugs taken orally affect both disease and normal tissues, thus increasing the chance of side effect and hypersensitivity. Hepatotoxicity is associated with some oral antifungal medications . In patients taking terbinafine concurrently with ketoconazole tablets causes serious ventricular dysrhythmias (in rare cases leading to fatality) have been recorded . For overcoming adverse consequences need arises to seek the solution through herbs . In the Unani system of medicine many herbomineral drugs are used empirically for treatment of Bahaq since antiquity but scientific documentation is not available. It has been planned to conduct a study entitled A Randomized parallel group open label standard controlled clinical study to Evaluate Efficacy and Safety of Unani formulations (Oral and Topical) in management of Bahaq (Pityriasis Versicolor) to generate evidence on scientific tools.
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