Evaluation the effect of herbal product based on henna (low sonia inermis), Myrtus communis and mastica(pistacia lentiscus) on men's androgenic alopecia: a randomized placebo controlled clinical trial

Evaluating the effects of herbal products Henna, Myrtus communis and Mastica on men's androgenic alopecia

A randomized controlled clinical trial with parallel groups, double blinded

The research is going to be conducted at the Research and Training Center for Dermatology and Leprosy. Both treatments are the same in appearance and packaging; and can only be differentiated by pharmaceutical codes on the boxes. The patient and the prescriber are not aware of the codes definition.

Inclusion criteria: men aged 18 to 60 years old; type 1 to 3 hair loss according to the Hamilton Hair Loss Criterion that has lasted more than 6 months; participants enrollment approval. Exclusion criteria: having sensitivity to components used in this study; history of G6PD; records of utilizing any topical products to prevent hair loss or stimulate hair growth; 5-α-reductase inhibitors and taking anti-androgenic drugs in the past 2 months; records of systemically given steroids for more than 14 days in the past 2 months; any active diseases in the head including scalp infection in the past 6 months; records of uncontrolled blood pressure or hypotension; any type of cancer or autoimmune diseases and hair transplantation.

Intervention group: traditional-medical lotion containing Henna leaf, Case leaf, Amla fruit, Mastic, 15 drops, twice a day, for 3 months. control group: 5% of hydro-alcoholic based drug as a placebo; same treatment as intervention group.

Number of hair strands; Terminal hairs to Volos; Hairs’ diameter; Physician satisfaction with treatment; Patient satisfaction of treatment

The assigning treatments method to patients is randomized and based on randomly permuted blocks with the block size of 6(using the related table to random permutations). The randomized list is provided by a statistical consultant. In this way, the group code of each patient who enters the study (in the order of patient admission) is determined based on a randomized list. These codes, which belong to the two groups of the traditional-medical lotion based on Henna and placebo have been determined by a statistical consultant; and in addition to patients, the researcher will not be informed until the end of the study so that can be conducted as a double blinded study.

Medication and placebo are identical in terms of appearance a packaging, only differentiated through the proprietary codes set by the pharmacist on the box of medicine. The patient and the prescribing researcher are not aware of the code. The outcomes of the study are prepared by the researcher who is unaware of the grouping and is blind to the groups and type of medications.