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.

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.”