A Study on Efficacy of Sufoof e Majeeth in the Management of Kalaf (Melasma)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Reducing the hyperpigmentary patches
研究概览
简要总结
ANNEXURE – 1
PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION
| 1 |
Name of candidate
Dr. SUMAIYA TABASSUM
|2
Name of institution
Govt. Nizamia Tibbi College , Hyderabad, Telangana
|3
Course of study and subject
MD (Unani) Tahaffuzi wa Samaji Tib
|4
Date of admission to course
11-4-2023
|5
Title of topic
**A study on “Efficacy of sufoof majeeth in the management of kalaf (Melasma)â€.
|6
Brief resume of intended work
| Need of the study:
A healthy body always reflects beautiful and glowing skin. The skin is the largest barrier between our external environment and us. It responds to environmental changes and reflects internal changes in our body. Today, majority of the population live in cities where they are exposed to dirt and pollution and pursue fast-paced and stressful lifestyle.
Melasma (kalaf) also known as “the mask of pregnancy†or “Chloasmaâ€, is a common ,acquired cutaneous pigmentary condition that results in mostly symmetrical, brownish pigmentation that affects the face.(24)
The cause of Melasma is unknown .But, probable factors include ultraviolet rays, estrogen-containing birth control pills, estrogen replacement therapy, ovarian or thyroid dysfunction, cosmetics, and hormonal disturbances.(5)
The prevalence of Melasma varies between 1.5% & 33.3% depending on the population. Its prevalence in pregnancy is around 50-70%.(23) The global prevalence of Melasma is approximately 1%.Women are more likely to develop the condition than men.(24) In men, the malar pattern is more common than the Centro facial and mandibular pattern.(23)
Due to the increased incidence, the condition has a significant psychosocial impact on patients, with patients reporting embarrassment, reduced self-confidence, anhedonia and a negative influence on interpersonal relationships and work productivity.(24)
The Unani System of Medicine believes in holistic approach to the prevention and treatment of diseases. In Unani System of Medicine drugs are obtained from natural sources and most of them are of plant origin. Natural cosmetics are more beneficial to our health and more effective than synthetic alternatives, and people today are beginning to demand total natural body care.
In unani literature there are so many topical single and compound drugs are available which are being used for the treatment of kalaf (melasma) and sufoof-e- majeeth is one of them.(26)
In the view of above facts, I would like to conduct a study to evaluate the efficacy of Sufoof Majeeth (L/A) in the management of kalaf (melasma).
REVIEWOF LITERATURE:-
UNANI LITERATURE**:**
In the unani system of medicine, melasma is known as jhaein (or) kalaf*.*(15)
According to Unani physicians, kalaf(melasma) is a skin disorder that is caused by morbid melancholic vapours (Galeez saudawi bukharat ).(6)
It is characterized by appearance of blackish spots on skin, smooth on touch.(7) These spots when spreads and forms a large patch, it is known as kalaf (melasma).These are more common and specific on the face. (8)
According to most of the ancient Unani physicians, the cause of kalaf (melasma) are those morbid melancholic vapours (galeez saudawi bukharat) that ascends upwards from the stomach towards the face and gets trapped beneath the skin due to the obstructive skin pores.(6)
It occurs more commonly in females, specifically in pregnant women due to the absence of menstruation (physiological amenorrhea) the morbid matter gets accumulated within the body.(9)
Other causes includes- excessive intake of black bile producing diets (Muwallid sauda aghzia) ,
Quartan fever (Humma rib),
Burnt melancholic sanguine (dam saudawi mohtariq),
Weakness of liver and spleen,
Sun exposure,
Improper digestion,
Impurity of blood,
hot and spicy foods. (10) (11) (14) (16)
This disease does not seem to be very painful but if measures are not taken to get rid of it ,it can ruin and disrupt the beauty of face.(13)
TYPES: It is of two types.(8)
- In first type the black bile (sauda) which is present in the stomach and the vapors of burnt blood (khoon-e-sokhta) evaporates and ascends up towards the skin of the face. In this type, abnormal humoral changes occurs in the stomach. The color of patches are greenish/ yellowish.
2.In this type ,the blood gets impure as its mixed up with the black bile (sauda) in the sub-cutaneous tissue and the vapours from this appears on the skin. The color of patches are blackish/ reddish black.
It should be treated with medicine which are cleansing and detergent (jaali advia)(7) (19)and followed by application of astringent paste immediately, so that the opening of vessels gets closed and does not let the blood accumulate beneath the skin. Apart from that when anti-inflammatory medicine used then astringent drug should be used in combination with it.(12)
| MODERN LITERATURE**:** |
Synonyms- Chloasma (3)/ Mask of pregnancy (2)
The term “Melasma†is derived from the Greek word “Melas†meaning black, pointing to the color of the clinical lesions.(25) It is an acquired, chronic, recurrent symmetrical hyperpigmentation of the skin, usually involving the malar regions, nose, sides of face, forehead and chin. (4)
Women (particularly Hispanic Or Indian) are more commonly affected than men.(1)
Epidemiology: (3)
Prevalence: Common problem.
Gender: Females more frequently affected.
Age: Incidence 30 to 50 years. Its incidence in pregnancy varies from 15 to 50% or more.(4)
Aetiology:
Melasma is a multifactorial disorder.(25)
The exact etio-pathogenesis is unknown, but there is a clear etiologic link to female hormone. (1 1)
It usually develops in association with:(4)
Oral contraceptives,
Pregnancy,
Cosmetics,
Photo toxic drugs,
Exposure to intense UV radiation’s.(4)
May be associated with endocrinological conditions such as thyroid disease. (24)
Morphology**:**
A grouped, well-defined, 2-5 mm, light to dark brown macules tend to coalesce in the center resulting in bigger brown patches. Macules remain more or less discrete at the periphery which becomes irregular in outline.
Pigmentation darker on sun exposure. (3)
Skin findings:
Symmetric brown patches, occurring on the forehead, cheeks, upper lip, and chin.(2)
Pattern of distribution: There are several distinct patterns including : (24)
• Centrofacial – located on the cheeks, nose, forehead and upper lip (excluding the philtrum) and is present in approximately 50-80% of cases.
• Malar – located over the nose and malar cheeks
• Mandibular pattern – located over the mandible and chin
• Extrafacial – This pattern is variable, but is predominantly located on the upper extremities, often on sun-exposed sites.
Differential Diagnosis: (24)
· Acanthosis nigricans
· Acquired dermal macular hyperpigmentation
· Actinic lichen planus
· Discoid lupus erythematosus
· Ephelides (freckles)
· Frictional melanosis
· Hori’s macules
· Naevus of Ota
· Ochronosis (exogenous) from hydroquinone use
· Poikiloderma of Civatte
· Post-inflammatory hyperpigmentation
· Solar lentigines
MANAGEMENT:
In conventional system of medicine there are potent drugs are easily available such as sunscreen creams/lotions, hypopigmentary drugs such as hydroquinone, kojic acid, azelaic acid, ascorbic acid chemical peels,triple therapy combination, tranexamic acid and laser therapy. These drugs produces various side effects such as skin irritation, rashes, allergy, transient hypochromia, leukoderma, permanent darkening of skin and blue-black pigmentation on the treated area.(3) (24)
Unani principle of treatment includes: (16)
Usool-e-ilaj: Evacuation of morbid matter/ black bile.
Tasfiya jild through jaali advia (detergent drugs).(16) (19)
Ilaj bi’l dawa (Pharmacotherapy) :
Local application of various drugs having anti-inflammatory,(12) cleansing & detergent(7) (19)properties
• Paste of Sufoof-e-majeeth along with rose water. (22) (26)
Ilaj bi’l-Tadbir (Regimenal therapy):
· Fasd,
· Steam,
· Inkebab,
· Zimad & Tila.
Dietary restrictions:
• Muwallid-i-sawda aghzia (black bile producing diets).(16) (20)
• Prolong use of eggs to be avoided. (16)
• Highly proteinaceous and spicy diets to be avoided. (20)
Tahaffuz (Prevention/ Precaution):
• Advia hirrifa (spicy drugs) to be avoided. (16)
• Avoiding sun at its peak. (1) (3)
| 6.3 |
AIM AND OBJECTIVES:
• The study aims at the Effect of the topical application of Sufoof-e-majeeth along with rose water in the management of kalaf ( melasma).
• To educate the patient regarding predisposing factors of kalaf(melasma).
• To create awareness about preventive measures of kalaf *(*melasma), there by preventing and decreasing it’s incidence and social stigma.
|7.0
MATERIAL AND METHODS:
|7.1
SOURCE OF DATA:
· OPD Skin and Cosmetology, Govt. Nizamia General Hospital, Charminar, Hyderabad, Telangana.
METHOD OF COLLECTION OF DATA:
· Data will be collected by pre-designed structured questionnaire which contains Open-ended questions.
INCLUSION CRITERIA:
· Clinical features with Melasma.
· Hyperpigmentation
· Sex: Either.
· Age: Above 20 and below 45 years.
EXCLUSION CRITERIA:
· Patients having age group below 20 and above 45 years.
· Patients suffering from any infective or contagious skin disease or under medication with antibiotics, antifungal, and steroids.
· Any kind of hereditary skin disorder.
· Patients taking oral contraceptive pills or injected depot contraceptive preparations.
· Patient allergic to any topical applications / known allergies to the compounds of majeeth.
· Patients who are not giving informed consent.
PARAMETERS FOR STUDY :
· Subjective Parameters:
Pt. Complaining of hyperpigmentation and patches.
· Objective Parameters:
The diagnosis is based on the history, clinical features, and clinical examination.
Von Luschan’s color scale.
Total Melasma Area and Severity Index (MASI) Score.
STUDY DESIGN: An experimental single arm before and after comparative study.
SAMPLE SIZE: A minimum of 30 patients
DURATION OF STUDY: 9 months.
PROCEDURE OF STUDY:
External medicines: (26)
· Zimad majeeth for external use at morning time for 1 month.
Zimad Preparation:
• Zimad will be prepared by using a fine powder of 1tea-spoon majeeth (Rubia cordifolia) mixed with 10 ml of rose water as a media for mixing and thick paste will be prepared out of it.
• The patients will be advised to clean the face with normal water followed by facial steam and application of Zimad on the affected area for 15 minutes, from medial to lateral direction once a day.
• Follow up will be done fort night where in patients will be enquired for changes in their symptoms and will be clinically assessed.
EVALUATION: Data will be analyzed statistically.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 45.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients with clinical features of melasma and hyperpigmentation patches.
排除标准
- •Patients of age group below 20 and above 45 years Patients with any other skin diseases and hereditary disorders who are not giving informed consent.
结局指标
主要结局
Reducing the hyperpigmentary patches
时间窗: 0th day | 07th day | 14th day | 21st day
次要结局
- Preventing and decreasing the incidence of melasma and social stigma due to it.(30th day)
研究者
Dr Sumaiya Tabassum
Govt Nizamia Tibbi College and General Hospital
