Clinical Research Project to Evaluate Effects and Fruitfulness of Unani Medicine in Treatment of Melasma (Hindi: Jhayeen)

Phase 2

Not yet recruiting

Conditions: Chloasma,

Registration Number: CTRI/2023/09/057430

Lead Sponsor: Jamia Hamdard (Deemed to be university)

Brief Summary: Although, melasma does not cause any major health related complications, it severely affects social life as well as emotional well-being of the patients. Patients commonly report feelings of dissatisfaction, low self-esteem, shame, anhedonia, and the lack of motivation to go out. Since melasma significantly affects psychosocial well-being due to the ugly patchiness of skin; therefore, the treatment of melasma in terms of its psychological complications is of particular importance.

Management of melasma is a substantial challenge. Topical, oral, procedural and combination treatments are used as conventional treatment of melasma. These are aimed at various aspects of the pathogenesis of melasma including photodamage, inflammation, vascularity, and pigmentation. Bleaching agents like phenolic compounds, hydroquinone, and its combinations like monobenzyl ether of hydroquinone (MBEH), Azealiac acid, combination with tretinoin (retinoic acid), kojic acid and hydrocortisone are used in topical ointments. However, all of these are associated with skin irritation, redness and more severe complications like epidermal atrophy, acne (seen with corticosteroids), exogenous ochronosis (seen with Hydroquinone) etc. More severe reactions like burning, itching, dryness, folliculitis, skin hypopigmentation, allergic contact dermatitis and secondary infection are also reported. Oral medications like Tranexamic Acid are known to cause abdominal bloating, menstrual irregularities, headache, and deep venous thrombosis.

Laser therapy, chemical peeling, micro needling, and cellular bio-stimulation by radiofrequency are popular procedural treatment of melasma. Although, procedural treatments have demonstrated a better efficacy in the long run, they are associated with adverse events such as burns, post inflammatory pigment alteration, peeling of skin etc. A high rate of recurrence, even after successful treatment is an important concern.

Keeping in mind the above facts, a need is felt where different and effective therapeutic option can be provided for the treatment of melasma without producing side effect. Unani medicines have been proved to be effective in curing various dermatological diseases. *Tila-e Kalaf* is an Unani Pharmacopoeial formulation, it is composed of *Masoor* (*Lens culinaris*) and *Badam Talkh* (*Prunus amygdalus*), and *Anjeer (Ficus carica)*. The paste of *Tila-e Kalaf* is prepared in the following steps:

1. *Masoor* (*Lens culinaris*) and *Badam Talkh* (*Prunus amygdalus*) are grinded and powdered separately and then mixed together in equal proportions.

2. The *Ficus carica (Anjeer)* is boiled to prepare its*JoshÄnda (*decoction*).*

*3. The powder of* Masoor and *Badam Talkh* is then mixed in *JoshÄnda* *Anjeer* for making paste and to be applied on face once daily.

In the year 2020, in the Dept. of Moalajat, Jamia Hamdard, New Delhi, a randomized standard controlled clinical study was conducted to evaluate the efficacy and safety of Unani formulation *Tila-e-Kalaf* in the treatment of Melasma. In the said study, the test group participants were treated topically with *Tila-e-Kalaf,* whereas the controlled group patients were treated with local application of standard topical formulation containing tretinoin 0.05%, hydroquinone 4.0%, and fluocinolone acetonide 0.01% gel. Treatment with *Tila-e-Kalaf* in test group was found more effective without producing any significant side effects as compared to the control group. However, in the test group, the patientâ€™s compliance was not quite as good as it could have been. A considerable number of patients faced inconvenience in applying *Tila-e-Kalaf* due to its non-sticky stuff and coarse particles, and due to cumbersome method of preparation. So, keeping this in view, it is planned to redesign the dosage form of *Tila-e-Kalaf* by converting it into a semisolid cream in anticipation to improve its efficacy and better patientsâ€™ compliance.

Therefore, in the present study, Pharmacopeial formulation *Tila-e-Kalaf* will be taken as a control to compare the efficacy of ***Kalaf* cream** in the management of ***Kalaf*** (Melasma).

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

Patients of all genders, belonging to 18 to 60 years of age and willing to participate in the trial voluntarily.
Clinically diagnosed patients of epidermal melasma using Woodâ€™s lamp (340-400 nm).
Patients willing to sign the informed consent form.

Exclusion Criteria

Pregnant and lactating women.
Female patient using oral contraceptives.
Patients having field work jobs.
Patients with drug or alcohol addiction.
Patients with uncontrolled diabetes mellitus, renal disorders, severe liver, and heart diseases.
Patients have used bleaching creams or topical steroid creams such as Azeliac acid, tretinoin and hydroquinone in the past 4 weeks before entering in the study.
Patients who have undergone any laser therapies and chemical peeling or consuming photosensitizing substances in past 4 weeks.
Patients having thyroid disorders.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in MASI Scale	1st,14th,28th,42nd,56th
Reduction in Melasma QoL Index	1st,14th,28th,42nd,56th
Reduction in PGA	1st,14th,28th,42nd,56th

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (1): Majeedia Unani Hospital
🇮🇳
South, DELHI, India
Majeedia Unani Hospital
🇮🇳South, DELHI, India
Dr Nushrat Jahan
Principal investigator
9278817191
NushratJahan@outlook.in