| 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
|
|
|
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
|
|
|
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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- 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.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [shobannandoliya732@gmail.com].
- 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.
- 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.” |