To evaluate the Safety and efficacy of Unani formulations Zimad e Bars in Kalaf (Melasma)

Phase 2

Recruiting

• Conditions: Chloasma, Kalaf (Melasma),

• Registration Number: CTRI/2015/11/006385
• Lead Sponsor: Central Council for Research in Unani Medicine

Brief Summary

This study is designed as a multicentric open trial in patients with **Zimad e Bars in Kalaf (Melasma)****.**After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically at baseline, 1st, 2nd, 3rd and 4th final follow ups. Each follow up will be carried out at the interval of two weeks. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be eight weeks. . Laboratory parameters for safety assessment will be conducted at baseline and end of study. 

Composition of *Zimaad e Baras*:

| | | | |

| --- | --- | --- | --- |

|**S. No.**

**ŪnÄnÄ« Name**

**Botanical Name**

**Weight**

|1.

***Bekh-e-Anjeer Dashti***

*Ficus carica Linn.*

100 g

|2.

***Babchi***

*Psoralea corylifolia Linn.*

100g

|3.

***Tukhm-e-Panwar***

*Cleome icosandra Linn. Syn. C. viscosa Linn.*

100g

|4.

***Narkachoor***

*Zingiber zerumbet Rosc ex Smith*

100g

|5

***Aab-e-Lemu***

*Citrus limon (Linn.) Burm.f.*

Q.S.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-13
• Last Update Posted: 2018-04-12

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

• Female Subjects with 18 to 65 years of age The patient presenting anyone or all signs mentioned below.
• Ill defined light brown to grey brown macules on Forehead 2.
• Ill defined light brown to grey brown macules in RMR 3.
• Ill defined light brown to grey brown macules on Chin.

Exclusion Criteria

• Patients with anyone of the following skin disease •Bahaq Aswad (pitryasis nigra) oNamash (Naevus).
• oBarash (lentigo) oKhÄ«lÄn (mole) oNishanate Quruh oFitzpatrick skin type grade 1 & 2 •Any systemic disorder requiring long term treatment.
• •Drug or alcohol addict •Subjects with oral contraceptive pills (OCPs) •Pregnant and lactating woman •Those who refuse to avoid cosmetics during study period Subject Selection •Female subjects with 18 to 65 years of age •The patient presenting anyone or all signs mentioned below.
• Ill defined light brown to grey brown macules on Forehead 2.
• Ill defined light brown to grey brown macules in RMR 3.
• Ill defined light brown to grey brown macules on Chin.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in signs and symptoms of Zimad e Bars in Kalaf (Melasma)	8 weeks

Secondary Outcome Measures

Name	Time	Method
Haematological and biochemical assessment for safety assessment	8 weeks

Trial Locations

Locations (3)

Clinical Research Unit Bhopal; 🇮🇳 Bhopal, MADHYA PRADESH, India

Regional Research Institute of Unani Medicine Kolkata; 🇮🇳 Kolkata, WEST BENGAL, India

Regional Research Institute of Unani Medicine, Chennai; 🇮🇳 Chennai, TAMIL NADU, India

Clinical Research Unit Bhopal

🇮🇳Bhopal, MADHYA PRADESH, India

DR AMIR FAISAL

Principal investigator

09827082483

dramir_faisal@yahoo.in