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CTRI Number  CTRI/2024/11/076340 [Registered on: 06/11/2024] Trial Registered Prospectively
Last Modified On: 06/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Unani 
Study Design  Single Arm Study 
Public Title of Study   Interventional study on participants of melasma with majeeth powder for better outcome. 
Scientific Title of Study   A Study on Efficacy of Sufoof e Majeeth in the Management of Kalaf (Melasma) 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sumaiya Tabassum  
Designation  Pg Scholar  
Affiliation  Govt Nizamia Tibbi College and General Hospital 
Address  Department of preventive & Social Medicine, OPD Division, Room No 102, Govt Nizamia Tibbi College and general hospital Charminar Hyderabad

Hyderabad
TELANGANA
500002
India 
Phone  6301042027  
Fax    
Email  Sumaiyat07@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mohammad Maqbool Hussain 
Designation  HOD Professor 
Affiliation  Govt Nizamia Tibbi College and General Hospital 
Address  Department of preventive & Social Medicine, OPD Division, Room No 102, Govt Nizamia Tibbi College and general hospital Charminar Hyderabad

Hyderabad
TELANGANA
500002
India 
Phone  9948679786  
Fax    
Email  maqboolahmar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sumaiya Tabassum 
Designation  PG Scholar 
Affiliation  Govt Nizamia Tibbi College and General Hospital 
Address  Department of preventive & Social Medicine, OPD Division, Room No 102, Govt Nizamia Tibbi College and general hospital Charminar Hyderabad

Hyderabad
TELANGANA
500002
India 
Phone  6301042027  
Fax    
Email  Sumaiyat07@gmail.com  
 
Source of Monetary or Material Support  
Govt Nizamia Tibbi College charminar hyderabad telangana 500002 india 
 
Primary Sponsor  
Name  Govt Nizamia Tibbi CollegeCharminarHyderabad 
Address  Department of AYUSH 23-1-1/G Govt Nizamia Tibbi College,Charminar,Hyderabad Telangana,India-500002 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sumaiya Tabassum  Govt Nizamia Tibbi College and General Hospital   Room no 101(OPD Skin and Cosmetology) Room no 102(OPD SPM)
Hyderabad
TELANGANA 
6301042027

Sumaiyat07@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Govt Nizamia Tibbi college Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L811||Chloasma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NA  NA 
Intervention  Zimad(Powder of majeeth with rose water)  1 tea spoon Powder of majeeth mixed with 10ml of rose water and thick paste will be prepared out of it.Patient will be advised to to apply the paste on affected area for 15 minutes once a day. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Patients with clinical features of melasma and hyperpigmentation patches 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reducing the hyperpigmentary patches  0th day
07th day
14th day
21st day 
 
Secondary Outcome  
Outcome  TimePoints 

Preventing and decreasing the incidence of melasma and social stigma due to it. 
30th day 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   17/11/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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)”.

 

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 “Chloasma”, 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).   

 

REVIEW OF 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)

1. 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.

 

 
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