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CTRI Number  CTRI/2025/02/080081 [Registered on: 07/02/2025] Trial Registered Prospectively
Last Modified On: 07/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Treatment of Hair loss with polyherbal unani oil 
Scientific Title of Study   Clinical study to assess the efficacy and safety of Rogan-i-Gesu Daraz in treating Intithar al-Sha‘r (hair loss) - a randomized, double-blind, standard controlled trial. 
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 NANDOLIYA SOBAN ARIF BHAI 
Designation  P.G SCHOLAR 
Affiliation  Luqman unani medical collage Hospital and research centre 12 Naubagh Vijayapura karnataka 
Address  Department of Moalajat OPD ground floor Luqman unani medical collage Hospital and research centre 12 Naubagh Vijayapura Karnataka 586101

Bijapur
KARNATAKA
586101
India 
Phone  8200257238  
Fax    
Email  shobannandoliya732@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Dafedar Abdul Rehman 
Designation  Associate Professor Dept. of Moalajat 
Affiliation  Luqman unani medical collage Hospital and research centre 12 Naubagh Vijayapura karnataka 
Address  Department of Moalajat OPD ground floor Luqman Unani Medical College Hospital and Research Center Vijayapura 586101

Bijapur
KARNATAKA
586101
India 
Phone  9032786832  
Fax    
Email  drdafedar1@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mamdapur Saba Abdul Razzak 
Designation  Professor Dept. of Moalajat 
Affiliation  Luqman unani medical collage Hospital and research centre 12 Naubagh Vijayapura karnataka 
Address  Department of Moalajat OPD ground floor Luqman Unani Medical College Hospital and Research Center Vijayapura 586101

Bijapur
KARNATAKA
586101
India 
Phone  9611497816  
Fax    
Email  dr.sabamamdapur@gmail.com  
 
Source of Monetary or Material Support  
Department of Moalajat OPD ground floor Luqman Unani Medical College Hospital and Research Center Vijayapura 586101 
 
Primary Sponsor  
Name  Luqman unani medical college hospital and research centre 
Address  Luqman unani medical college hospital and research centre 12 Naubag opposite star function hall Vijayapura Karnataka India 586101 
Type of Sponsor  Private 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 Nandoliya Soban Arif Bhai  Luqman unani medical college hospital and research centre  Ground Floor Room no 1, General OPD, Department of Moalajat, LUMC,586101 Bijapur KARNATAKA
Bijapur
KARNATAKA 
8200257238

shobannandoliya732@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Communication of Decision of the Institutional Ethical Committee (IEC) For Bio Medical Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L659||Nonscarring hair loss, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Coconut oil  Form Oil Mode of application Topical Dosage Quantity sufficient once daily Follow up 0th 15th 30th 45th 60th Day after treatment 
Intervention  Rogan-i-Gesu Daraz  Form Oil Mode of application Topical Dosage Quantity sufficient once daily Follow up 0th 15th 30th 45th 60th Day after treatment 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details 
An individual who tests positive on a hair pull test and has a history of hair
loss
Individuals who are willing to voluntarily provide informed consent to participate
in the trial 
 
ExclusionCriteria 
Details  pregnant or currently lactating women
participants with prior systemic disorders
participants with scalp lesions
participants not on any others treatment options 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
5-point Likert scale (hair growth, hair count, hair thickness, and hair shining)
visual analogue scale (VAS) 
Primary outcome will be measured at every follow up 
 
Secondary Outcome  
Outcome  TimePoints 
Global photographic assessment
Hair Loss Impact Questionnaire 
Measured at baseline and end of the treatment 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   19/02/2025 
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="1" 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [shobannandoliya732@gmail.com].

  6. For how long will this data be available start date provided 24-01-2026 and end date provided 03-01-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nill
Brief Summary  
Hair loss, also referred to as baldness or alopecia, is a condition marked by the absence or reduction of hair in areas where it normally grows. It can present as patches or overall
thinning, and it may be temporary or long-lasting. Alopecia can affect people of all ages and genders.[1] Broadly, alopecia is of two types, i.e., non-cicatricial and cicatricial types, In Non-cicatricial, the Scar is absent and the skin looks normal, Hair follicles are not destroyed, the follicular opening is visible and hair loss is expected to reverse. Cicatricial – Scars are present, skin looks shiny and wrinkled, Hair follicles are destroyed, and the follicular opening is not visible, signs of inflammation are present as erythema. [2] In nonscarring alopecia, the hair follicles remain intact, meaning that hair loss can be reversed, and hair can grow back. Examples of nonscarring alopecia include androgenetic alopecia,
alopecia areata, telogen effluvium, anagen effluvium, traction alopecia, trichotillomania, and alopecia syphilitica, among others. (1) In scarring alopecia, the hair follicles are damaged in a way that they can’t grow back. This leads to permanent hair loss. Scarring alopecia are
classified as primary and secondary. Primary scarring alopecia are lymphocytic,
neutrophilic, and mixed types. (2) most common Lymphocytic primary cicatricial alopecia are frontal fibrosing alopecia (FFA), lichen planopilaris (LPP).[1,3]
Male pattern baldness is prevalent in 58% of Indian men aged 30–50, while in women, hair fall affects 40.70% of cases. Female pattern hair loss follows at 22.09%, alopecia areata at 12.81%, and male pattern hair loss at 7.49%. Female pattern hair loss prevalence increases from 12% in women aged 20–29 to over 50% in older women.
In 2019, a study was done at multiple centres to look at how often different types of hair loss occur in patients visiting specialized hair clinics and to see if there are differences in these patterns around the world. The study included over 3000 diagnoses of alopecia, with 73% being nonscarring and 27% scarring. Nonscarring alopecia frequency - Androgenetic
alopecia 37.7%, Alopecia areata 18.2%, Telogen effluvium 11.3% Scarring alopecia frequency - Frontal fibrosing alopecia 10.8%, Lichen planopilaris 7.6%, Folliculitis decalvans 2.8%. The figures vary widely. Before menopause, about 10% of women
show signs of androgenetic alopecia, while after menopause, 20–30% of all women can be affected.[4]
Minoxidil, derived from piperidine-pyrimidine, acts as a potent vasodilator when applied
topically twice daily in a 2% solution, resulting in the conversion of some miniaturized hair in approximately one-third of men and 55% of women. However, a notable side effect is local irritation. While a 5% minoxidil solution may yield better outcomes, it’s not recommended for women due to the potential risk of hypertrichosis from absorption.[1,5]
Cyproterone acetate, administered at doses of 50-100 mg, may halt further hair loss progression. Combining 2 mg of the drug with ethinyl estradiol can help sustain
improvement in women experiencing early-stage hair loss, despite side effects such as
lethargy, weight gain, breast tenderness, decreased libido, and nausea.[6] Spironolactone might offer subjective improvement, but patients often report mood swings, irregular
menstrual cycles, and breast tenderness. Flutamide, a pure anti-androgen, has shown short- term effectiveness, yet poses a risk of hepatotoxicity. Finasteride, a selective inhibitor of the type 2 isoenzyme of alpha-reductase, which converts testosterone to dihydrotestosterone, is contraindicated in pregnant women or those planning pregnancy. [7]Prolonged PUVA (Psoralen ultraviolet A) therapy may stimulate regrowth of scalp and body hair. [8]
Conversely, certain drugs can cause diffuse hair loss, including allopurinol, beta blockers, borax, bromocriptine, carbamazepine, colchicine, cyclophosphamide, doxorubicin, heparin, lithium, mercury, petressin, retinoids, sodium valproate, thallium, and triparanol. [9]Given the limitations of conventional treatments for hair loss, there is a rising interest in exploring alternative therapeutic options. Traditional medicine systems such as Unani medicine provide potential remedies for hair loss by leveraging ancient healing practices. This study
aims to identify a safe and effective treatment for hair loss, specifically evaluating the safety and efficacy of Rogan-i-Gesu Daraz.[10,11] through a double-blind randomized controlled trial titled, “Clinical study to evaluate the safety & efficacy of Rogan-i-Gesu Daraz in treatment of Intithar al-Sha‘r (Hair loss)-A randomized double-blind standard controlled trial.”
 
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