PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1. / Name of the Candidate and Address / MUNAWWAR GAURI P.G SCHOLAR, DEPARTMENT OF MOALAJAT, NATIONAL INSTITUTE OF UNANI MEDICINE, KOTTIGEPALYA, MAGADI MAIN ROAD,BANGALORE- 91.2. /
Name oFthe Institution
/ NATIONAL INSTITUTE OF UNANI MEDICINE, BANGALORE.3. / Course of study and subject / M.D MOALAJAT
4. / Date of Admission to course / 15.11.2011(BATCH 2011-12)
5. /
Title of the study
/ THERAPEUTIC EvaluatION OF ZIMAD (TUKHME TURB, TUKHME KARAFS AND SIRKA) IN KALAF (melasma) - A SINGLE BLIND RANDOMIZED CONTROLLED STUDY.6. /
Brief resume of the intended work
6.1 / Need for the study :Kalaf (Melasma) is one of the common skin disorders that are observed mostly in females; men comprise only 10% of cases and demonstrate the same clinico pathological features as in women.1, 2, 3 It affects all racial and ethnic groups but is most prevalent in darker complexioned individuals especially in women living in areas with intense ultraviolet radiations.1 It is more common and troublesome in darker Mediterranean and Asian skin types. 60% of pregnant women and 30% of women on oral contraceptives pills develop melasma.3,4 This skin disorder is more common in the age group between 15-50 years.5
Melasma is described as Kalaf in nearly all classical Unani books. Unani physicians have been treating this disorder since long back and have described various drugs possessing the Jali & Muhassine laun properties for the treatment.6,7 Although effective treatment is available in conventional medicine but recurrence rate is high after discontinuing the treatment.
Though, this disorder has no impact on general health of patient but it certainly has psychological impact. Further, chances of recurrence also add to the stigma and agony of the sufferers.
Keeping in view all above facts, the present study entitled “Therapeutic Evaluation of Zimad (Tukhme turb, Tukhme karafs and Sirka) in Kalaf (Melasma) - A Single Blind Randomized Controlled Study.” is designed.
6.2 / Review of literature:
Kalaf is a pigmentation disorder of skin comprehensively described in classical Unani literature .According to renowned Unani physicians like Ibn Sina, and Akbar Arzani it is caused by admixture of black bile (sauda) with blood in layers of skin that leads to its alteration and it gets expressed over skin as blackish or brownish spots.7,8,9,
In conventional medicine Kalaf is synonymously described as melasma. It is defined as a common acquired symmetric hypermelanosis characterized by irregular light brown to grey brown macules involving sun exposed areas.1,10 There is predilection for cheeks, forehead, upper lips, nose and chin areas.1 Commonest type of melasma is centrifacial (65%), the malar type with pigmentation on cheeks and mandibular pattern with pigmentation over lower jaws are less common.4 Some of the predisposing factors for melasma are exposure to UV radiations, genetic influences, oral contraceptive, cosmetics, phototoxic and anticonvulsant drugs.1
In Unani medicine kalaf is treated on the principle of elimination of disease causing substances.9,11 Thereafter the drugs possessing properties like Muhalil, Jali and Muhassine laun are used locally in the form of Zimad.7
6.3 / Objectives of the study:
To evaluate the safety and efficacy of Zimad of tukhme turb, tukhme karafs and sirka in the management of Kalaf (Melasma).
Material and Methods:
7.1 /
Source of Data:
Moalajat OPD and IPD of National Institute of Unani Medicine, Bangalore.
7.2 / Method of Collection of data:
Through clinical study of patients visiting OPD and IPD of NIUM, Bangalore.
Subjective Parameters:
· Brown or Blackish pigmentation
Objective Parameters:
· Melasma area severity index.12
· Photographs of lesions.
Inclusion Criteria:
· Clinically diagnosed patients of Kalaf.
· Patients of both genders
· Patient’s between15-50 years of age.
Exclusion Criteria:
· Any concomitant disease diagnose by clinical examination and history .
· Skin sensitivity.
· Pregnancy.
Sample size:
· Total patients : 40
· Test Group : 20 patients.
· Control group : 20 patients.
Study design:
· Parallel group, Randomized, Single blind study with standard control.
Procedure of Study:
Diagnosed patients of Kalaf, qualifying the inclusion criteria, will be divided randomly into test and control groups after having their informed consents. Test group will comprise of 20 patients who will be given test drug in the form of Zimad once a day for a period of 45 days. Control Group will comprise of 20 patients in which standard drug, Azelaic acid 10% cream,13 will be applied topically once a day for the same duration.
Test Formulation. 14
Tukhme Turb (Seeds of Raphanus sativus)
Tukhme Karafs (Seeds of Apium graveolens)
Sirka (Vineger)
Drug dosage:
The above first two ingredients will be taken in equal amount and pulverized to make fine powder. This will be mixed with required amount of Sirka to make paste for local application over the affected area once in a day for 10 minutes in the form of zimad.
Standard drug:
Azelaic acid 10% cream.13
Route of administration:
In patients of test group, Unani formulation in the form of zimad will be applied topically once a day for 10 min for 45 days. In control group, Azelaic acid 10% cream will be applied locally for the same duration.
Duration of Protocol: 45 days.
Follow Up: Zero, 15th, 30th and 45th days.
Duration of study: One and half year.
7.3 / Does the study require any investigations or interventions to be conducted on patients or humans or animals? / Yes
Hb%, TLC, DLC, ESR
7.4 / Has ethical clearance been obtained from your Institution in case of 7.3 / Applied for
8. / List of references:
1. Sams WM. Principles and Practice of Dermatology. 2nd Ed. Singapore: Churchill Livingstone; 1996: 832.
2. McKee PH. Pathology of the Skin. 3rd ed. USA: Elsevier Limited; 2005: 1007.
3. Shah SN. API Test Book of Medicine. 8th ed. Mumbai: The Association of Physicians of India; 2008; 1412.
4. Marks R. Roxburgh`s Common Skin Disease. 17th Ed. New York: Oxford University Press; 2003: 238.
5. Behl P.N. Practice of Dermatology. 9th Ed. New Delhi: Satish Kumar Jain for CBS Publishers; 2004: 298-300.
6. Najmul Ghani, Khazain ul advia. New Delhi: Idara Kitabus Shifa; YNM: 1275-76.
7. Ibn Sina. Al Qanoon Fil Tib. New Delhi: Idara Kitabus-Shifa; YNM: 1422-24.
8. Arzani A. Tibbe Akbar, Urdu translation by Hussain M. Deoband: Faisal Publication; YNM: 733-34.
9. Baghdadi Ibn Hubal. Kitab Al Makhtarat fit Tibb. (Urdu translation by CCRUM) Vol-4. New Delhi:Ministry of Health and Family Welfare, Govt. of India; 2007: 118-19.
10. Khan Ajmal. Al-Haziq. Karachi: Madina Publishing Company; 1983: 550-52.
11. Majoosi, Kamilus Sana. Vol-2. New Delhi: Idara kitabus Shifa; 2010; 257-59.
12. Bohr U et al. Scoring System in Dermatology, Indian J Dermatol Venerol Leprol. July-Aug 2006: 72(4); 318
13. Tripathi KD. Essentials of Medical Pharmacology. 5th Ed. New Delhi: JPBM Publishers; 2004: 799.
14. Khan Azam. Akseer Azam, Vol.4, Matba Nizami Kanpur; 1289 Hijri: 494-500.
9. / Signature of Candidate
10. / Remarks of the Guide
11. / Name & Designation of
11.1 Guide
11.2 Signature
11.3 Co- Guide
11.4 Signature
11.5 Head of Department
11.6 Signature
12 / 12.1 Remarks of the Chairman & Principal
12.2 Signature
4