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CTRI Number  CTRI/2024/10/075415 [Registered on: 17/10/2024] Trial Registered Prospectively
Last Modified On: 15/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Unani Medicine in Dandruff 
Scientific Title of Study   A Comparative Study on Efficacy of Luaab Hulba vs Joshanda Khubbazi as Ghasool in Huzaaz(Pityriasis Capitis) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shaistha Banu 
Designation  PG Scholar 
Affiliation  Government Unani Medical College and Hospital 
Address  Department of Amraze Jild wa Tazeeniyat, Room no.8, Government Unani Medical College and Hospital Dr.Siddaiah Puranik Road, Basaveshwaranagar, Bangalore

Bangalore
KARNATAKA
560079
India 
Phone  9632537156  
Fax    
Email  drsyedshaisthabanu@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ayesha Tabasum 
Designation  Professor and HOD 
Affiliation  Government Unani Medical College and Hospital 
Address  Department of Amraze Jild wa Tazeeniyat, Room no.8, Government Unani Medical College and Hospital Dr.Siddaiah Puranik Road, Basaveshwaranagar, Bangalore

Bangalore
KARNATAKA
560079
India 
Phone  9035158024  
Fax    
Email  ayesharafeeq81@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Ayesha Tabasum 
Designation  Professor and HOD 
Affiliation  Government Unani Medical College and Hospital 
Address  Department of Amraze Jild wa Tazeeniyat, Room no.8, Government Unani Medical College and Hospital Dr.Siddaiah Puranik Road, Basaveshwaranagar, Bangalore

Bangalore
KARNATAKA
560079
India 
Phone  9035158024  
Fax    
Email  ayesharafeeq81@yahoo.com  
 
Source of Monetary or Material Support  
Government Unani Medical College and Hospital,Bangalore 560079 
 
Primary Sponsor  
Name  Government Unani Medical College and Hospital 
Address  Dr.Siddaiah Puranik Road, Basaveshwaranagar, Bangalore, Karnataka, India- 560079  
Type of Sponsor  Government medical college 
 
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 
Dr Shaistha Banu  Government Unani Medical College & Hospital  OPD/IPD of Government Unani Medical College & Hospital Dr Siddaiah Puranik Road Basaveshwaranagar Bangalore
Bangalore
KARNATAKA 		 9632537156

drsyedshaisthabanu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee(IEC) for Biomedical Research, Government Unani Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L210||Seborrhea capitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Tukhm Hulba(Trigonella Foenum) locally  Luaab Hulba is prepared by soaking the required quantity of powdered Tukhme Hulba overnight in water. Apply over the scalp for 5mins and washed, this is done every alternate day for 30 days. 
Comparator Agent  Tukhme Khubbazi(Malva Sylvestris) locally  Joshanda-e-Khubbazi is prepared by boiling coarsely powdered Tukhme Khubbazi which was soaked overnight in water till water reduces to half of its volume then filter it. wash hair with above decoction, this is done every alternate day for 30 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients of age group between18-50 years.

Patients of all genders.

Clinically diagnosed patients of mild to moderate Pityriasis Capitis.

Patients with ASFS Score ≤30.
 
 
ExclusionCriteria 
Details  Patients diagnosed with other scalp and skin diseases like tinea capitis, moderate to severe form of seborrheic dermatitis, pediculosis capitis, scalp psoriasis, folliculitis, etc.

Patients on systemic drugs like steriods, anticoagulants, immunosuppressants and antitumor drugs.

History of any treatment for PC within previous one month.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Dermoscopy

2.Decrease in Adherent Scalp Flaking Score (ASFS)
 		 1. 0th day and 30th day

2.0th day, 10th day, 20th day, 30th day

 
 
Secondary Outcome  
Outcome  TimePoints 
1.Decrease in Score of Scalpdex Quality of Life Index Questionnaire

2.Changes in Photography of the Scalp 		 1.0th day, 10th day, 20th day, 30th day

2.0th day and 30th day
 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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)   01/11/2024 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Pityriasis Capitis is also known as Dandruff or Pityriasis Simplex/ Sicca/ Capillitii or Seborrhea confined to scalp. Huzaaz is termed as Dandruff i.e Pityriasis Capitis (PC). Huzaaz is also known as Bafa, Hibriya, Hubayra, Qishr al Raas, Saboosa. Huzaaz is derived from Arabic word which means multiple tiny thin exfoliative particles of the scalp skin.

Pityriasis Capitis (PC) is a common scalp disorder that has occurred from centuries.  It is characterized by desquamation of the outermost layer of scalp skin which causes shedding of greyish white flakes, itching, irritation mostly caused by a yeast like fungus Malassezia species. It is the mildest form of Seborrheic dermatitis  which  is  confined  only to scalp with minimal to no inflammation and erythema.

The worldwide prevalence of PC is about 46-50% whereas in South Asia, it is 60.1%.  The  Incidence of PC among Adults is 42% and Adolescents is 1-3%.  PC is one of the major problem among adolescent. In South India, PC is common in the age group of 17 years. Men are more affected than women. They also experience hair loss which precede to Telogen Effluvium, androgenic alopecia. In a study, 100-300 number of hair were shed in PC sufferers instead of 50-100 in normal subjects.

Nowadays, PC is becoming the major and most common problem of hair. The greyish white flakes are often visible on the hair and shoulders with scalp soreness. Itching due to PC causes great embarrassment to the individual in public. The scaly scalp looks unhygienic and untidy. It affects the self-esteem, self-conscious, and self confidence in one’s quality of life.

 

Various Topical Antifungal agents are available for the management of PC like Ketoconazole, Zinc Pyrithone, Selenium Sulphide, Cetyl Alcohol. But these medicines have many adverse effects like skin irritation, allergy, hair breakage, skin discoloration, unexpected hair colour and also cancer. Despite availability of variety of treatment, the complete cure is far from reach, expensive and sensitive to hair. Hence the herbal drugs are eco-friendly and also safe due to negligible side effects.

 

In Unani System of Medicine, the Principles of treatment in Huzaaz is Tanqiya-e-Mawad. Various single and compound formulations can be used topically which possess properties like Mulattiff(demulcent), Jali(detergent), Muhallil(anti-inflammatory). Single drugs include Amla, Arad Tukhm-e-Baqla, Bhangra Siyah, Brinjasif, Nukhood, Chukandar, Hina, Hilteet(Hing), Anjeer, Irsa, Kateera, Khardal, Khatmi, Khubbazi, Kundur, Leemu, Lehsun, Luabe Isaphgol, Maghze Tukhme Kharpiza, Muqil, Parsiyaoshan, Poste Halela, Rasaut, Saboos e Gandum, Simaghe Arabi, Sibr(yelwa), Sirka, Suddab, Tukhme Hulba, Tukhme Katan, Tukhme Sosan, Turmus, Ushaq, Zarawand madharij, Zarnikh. Compound drugs include Roghane badam talq, Roghane Banafsha, Roghane Gandum, Roghane Kadu, Roghane Zaitoon.

 

However, these drugs have not been scientifically explored so far to provide safe, more effective and economical treatment for Huzaaz Thus, the present study entitled “A Comparative Study on Efficacy of Luaab Hulba vs Joshanda Khubbazi as Ghasool in Huzaaz (Pityriasis Capitis)” is designed to validate its efficacy.

 

 
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