A clinical study of kalaf(melasma) with therapeutic evaluation of tila tukhm-e-jarjir (Eruca sativa linn.)and tukhm-e-turb(Raphanus sativus var.longipinnatus) in its management ; A block randomised single blind standard controlled study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Brown and Black Pigmentation measure by physicians assessment scale.
研究概览
简要总结
Kalaf (Chloasma or Melasma ), is a sharply, irregular, bordered, hyperpigmented area most
often on the forehead and cheeks, and rarely on the upper chest and extremities, the pattern
almost forming a mask. The color is usually light brown but darkens with sun exposure. The
disorder is slowly progressive and chronic and the disease mainly occurs in summer.
The main etiology is not known but some cases are seen in during pregnancy (“mask of
pregnancyâ€) or with longtime illness. Women on contraceptive pills also develop chloasma or
Melasma. Incidence of this disorder in pregnant lady is almost 60 percent and women on
contraceptive pills is almost 30 percent.Mostly occurs in age group between 30 to 55 years
and rarely in case of minor and after menopause.
Melasma word is derived from Greek word “Melas†meaning black. Its prevalence is high
in individuals of Asia, Latin America and people of Hispanic origin and in Fitzpatrick skin
type 3-5 .Its prevalence in india is almost 0.25% to 4% and skin disorders are very well recognised
since Greek Arabic Period.
According to Classical Unani Books, the main cause of Kalaf is accumulation of
Sauda(Black Bile) under the layer of skin.9 Kalaf Or Jhhaien Or Melasma is almost
described in all Classical Books of Unani and Council‟s authenticated Books like Al-
Moalajat-al-Buqratiya, Al-Havi etc.
In modern system of medicine, Melasma is treated by various ways like topicals creams e.g
Kojic Acid, Hydroquinone, Azelaic Acid or by oral drugs like Glutathione, Tanexamic Acid
etc or with combination of oral and topical drugs.11 Some therapies are also available for
Melasma like micro needle insertion with some chemicals or chemical peelings or some
Lasers etc. These treatments have some adverse effects like itching, redness, irritation,
allergy from topical creams.The effect of this disease on general health is nil. But it creates
problems in social life. This disease has negative impact on life. Melasma is very frustrating
disorder to treat and one with significant psychosocial implications. Keeping in view of the
above facts, the present study entitled
“A Clinical Study Of Kalaf (Melasma) With Therapeutic Evaluation Of Tila Tukhm-e -
Jarjir(Eruca Sativa linn.) And Tukhm-e-Turb(Raphanus sativus var.Longipinnatus) in its
Management ; A Block Randomised, single blind, Standard Control Studyâ€.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Clinically diagnosed patients of Kalaf.
- •Patients irrespective of gender.
- •Patients in the age group of 18 to 60 years.
排除标准
- •Known cases of skin allergy or sensitivity as revealed by history and clinical examintaion.
- •Pregnant and Lactating Women and Patients on Oral Contraceptives.
- •Diseases requiring long term treatments (Including Uncontrolled Diabetes Mellitus, Cardiovascular Diseases, Chronic Renal Diseases, Chronic Liver Diseases) Diagnosed by History of patient and Clinical Examination.
- •Unwillingness or inability to fill the protocol.
- •Patients who fail to give the informed consent.
结局指标
主要结局
Brown and Black Pigmentation measure by physicians assessment scale.
时间窗: day 0, day 7, day 14 , day 21 and day 29
Irregular, sharp, black and brown hyperpigmented macules measure by Likert Scale.
时间窗: day 0, day 7, day 14 , day 21 and day 29
次要结局
- photographs of the hyperpigmented macules or lesion. Identity and also the photographs clicked will be placed in such a manner that his or her eyes are not revealed and hence the confidentiality will be maintained.(Melasma Area Severity Index (MASI))
研究者
Dr Mohammad Sheeraz Mushtaque Ahmed
Regional Research Institute of Unani Medicine
