Prevalence- Melasma is the skin disease which have high prevalence rate of 1.5% to 33.3%. In a Prospective study conducted on Indian male by Sarkar et al.in a tertiary care hospital in India, the prevalence of Melasma was found to be 20.5% in men. Melasma, however, affects women more commonly than men. An Indian study of 312 patients with Melasma found a 4:1 female to male ratio. Most common time of onset of Melasma was post pregnancy (42%), whereas 26% of patients developed it during pregnancy.

NEED OF STUDY- Therapeutic management of Melasma is challenging, with high recurrence rates which significant impacts on the quality of life. Systemic treatments with Tranexamic acid and polypodium leucomatous, etc. topical hydroquinone, Micro Needling, Peeling, and Laser have many side effects.These have potential drawbacks like irritation and rashes. Recurrence is also very high in these patients after discontinuation of the therapy. In Ayurveda, various studies have been carried out for the treatment of the Vyanga. These mainly focus on local medication/application like Lepa, Taila etc. Vyanga is a Raktapradoshaj Vikara therefore, vitiation of the Rakta Dhatu is the main event in the pathology. Jalauka is primarily used for Raktamokshna in the management of these diseases to alleviate Rakta Dushti. The role of Jalaukacharana in the management Vyanga is not studied till date. Therefore, this study is designed to compare the efficacy of of Jalaukavacharana and Mukhakantikar Lepa in Vyanga treatment.

Research Gap Analysis- There is no work done on comparative study of Jalaukavacharana and Mukhakantikar Lepa in Vyanga. To fill this knowledge gap, this study is planned.                                                                                

SELECTION OF DRUGS- Ayurvedic treatment is conducted in two ways i.e. Shamana Chikitsa and Shodhana Chikitsa.

Shamana Chikitsa include Prakshalana, Abhyanga, Lepana, Udvartana, Nasya, Rakta Mokshana, etc. Acharya Sushruta has advised Lepa, Shodhana therapy, Siravedha Karma in Vyanga.

Jalauka are selected for the management of Vyanga. Jalaukavacharana is primarily employed in the Dushti of Rakta Dhatu by Vata and Pitta Dosha. Jalauka causes Srotosodhana locally by removing the deeply seated Dosha in the Twacha. Its help in subsiding all the associated symptoms of Vyanga. Pathological changes in Pitta Dosha, Twak Vaivarnya are produced in Vyanga Roga.

The drug Manjistha is mentioned in Varnya Mahakashaya in Charaka Samhita. Its stimulates Dhatwagni. Its Kapha-Pittahara properties pacify the aggravated Kapha, Rakta, and Vata Dosha. Also, it has a Raktashodhaka, Kaphagna, Shothaghna, Kushthaghna, etc. properties. Vyanga is characterised by Shyava Varna Mandala which decreases the luster of skin so Manjistha with properties like Kashaya-Tikta-Madhura Rasa, and Varnya becomes the drug of choice.

The selected drug for local application, Mukhakanikar Lepa contains Yava, Yashtimadhu, and Lodhra. These ingredients are Madhura, Kashaya in Rasa, Sheeta in Virya, which are Pittashamaka in Guna. All these ingredients are Varnya, Pittashamaka. According to Acharya Sushruta, the disease Vyanga is manifested due to disturbed state of Vata and Pitta. It is already proven effective in treating Vyanga in previous studies.

These ingredients are easily available and cost effective, so in this study Manjistha and Mukhakantikar Lepa are selected for the management of Vyanga.

JALAUKAVACHARANA

In Ayurveda, most of disease can be managed with Shodhana (bio-purification method), Samshamananm (pacification, palliative treatment) and Nidana Parivarjanam method.

For the Rakta Pradoshaja Vyadhi, Raktmokshana should be considered as the supreme method. Aacharya Sushrut mention the many benefit of Raktmokshana. It not only purifies the channels but also let the other parts become free from disease and its action is faster than other remedies.

SELECTION OF LEECH: Yogya Jalauka (Nirvisha Jalauka)

STORAGE: After collecting the Jalauka they should be kept in a wide and new pot filled with pool water and ooze or slime. On every second and third day the water should be changed and feeding should be dropped inside the pot. After five or seven days the pot should be changed.

Jalaukavacharana: After collecting the leech, It will be Stored in clean fresh water jar and the water will be changed in every three or five days.every time for the new patient, fresh Jalauka will used and they were reused after 7 days.

RESEARCH QUESTION- Is there any difference in the efficacy of Jalaukavacharana and Mukhkantikar Lepa in Vyanga?HYPOTHESIS: 

NULL HYPOTHESIS (H₀): There is no difference between the efficacy of Jalaukavacharana and Mukhakantikar Lepa in Vyanga .

ALTERNATIVE HYPOTHESIS (H₁)- There is difference between the efficacy of Jalaukavacharana and Mukhakantikar Lepa in Vyanga .

AIM- To compare the efficacy of Jalaukavacharana and Mukhakantikar Lepa in Vyanga

OBJECTIVES:

Primary objective: To study the physiological concept of Twak focusing on Vyanga and to compare   efficacy of Jalaukavacharana and Mukhakantikar Lepa along with Manjistha Ghan Vati in Vyanga

Secondary objective: To compare the efficacy of Jalaukavacharana and Mukhakantikar Lepa in Vyanga

Material AND METHODS:

Study Design:

Computerised Randomization

Comparative

Prospective

Interventional study

Study Type: Clinical Study

Phase of Clinical Trail: II

Number of groups: 2 groups

Group A- In 20 patients of Vyanga- Jalaukavacharana will be administrated once a week and Manjistha Ghan Vati 250 mg 2 BD will be given after meal (Luke warm water).

Group B- In 20 patients of Vyanga - Mukhakantikar Lepa OD (Base-Water) in morning and Manjistha Ghan Vati 250 mg 2 BD will be given after meal (Luke warm water).

Site of Study:

 The study will be conducted in patients of Vyanga registered in OPD and IPD of National Institute of Ayurveda Hospital and SSBH, Jaipur.

 Study setting:

 OPD and IPD of National Institute of Ayurveda Hospital and SSBH, Jaipur. 40 patients of Vyanga will be randomly selected according to inclusion criteria from those who are visiting the OPD & IPD of National Institute of Ayurveda. Patients will be categorized into two groups, namely Group A and Group B, each group containing 20 patients. Informed written consent will be taken from the patients prior to commencement of the trial.

 Study Duration: 18 months

 Ethical aspects:  Ethical clearance will be taken from Institutional Ethics Committee, National Institute of Ayurveda, Jaipur

 Participants of Interest: Patient who are visiting in OPD and IPD of National Institute of Ayurveda Hospital and SSBH, Jaipur.

Sampling method: Convenience Sampling

Sample size:  Total 40 patients. Group A (20) OR Group B (20)

Sample size calculation: At 95% confidence level and 80% power & using previous study data S.D.=3.53

Diff.of mean=1.76

Sample Size-42 for each group

But due to limited period of time (18 months) and budget the sample size of 20 for each group is fixed for the present study

Screening criteria: Patients of Vyanga who will fulfil the inclusion criteria irrespective of gender, religion, occupation and socio-economic status.

Patients who are diagnosed with Vyanga will be selected from the OPD and IPD of National Institute of Ayurveda Hospital and SSBH, Jaipur.

Diagnostic criteria:

The diagnosis will be made on the basic of Ayurveda as well as Modern aspect of signs and symptoms.

A special Proforma will be prepared to diagnose the patients of Vyanga as mentioned in classics.

Withdrawal criteria:

During the course of trial, if any serious illness or any adverse effects. appears which requires urgent treatment.

Patients himself/herself want to withdraw from the clinical trial.

Referral Criteria:

In the occasion of any adverse drug reaction or Adverse drug event.

GROUPING:

Group A: Jalaukavacharna +Manjistha Ghan Vati

Jalaukavacharana- One sitting per Week (total 8 sittings /7 days interval) will be given for 60 days.

Manjistha Ghan Vati-250mg (2 tab)/ BD, after meal with lukewarm water for 60 days.

Group B: Mukhakantikar lepa + Manjistha Ghan Vati

Mukhakantikar Lepa:

Thickness- 1/2 Angula Pramana/one time (base-water) applied in Morning.

Duration- Lepa Should not be removed before it gets dried.

Manjistha Ghan Vati-250mg (2 tab)/ BD, after meal with lukewarm water for 60 days.

 DURATION OF CLINICAL TRIAL AND FOLLOW UP STUDY:

Total Duration of Trial: 60 days.

 Follow up during treatment:

Assessment of the all subject will be done after each 15 days (on 0^th day, 15^th 30^th 45^th & 60^th days) during the trial in both groups.

Follow up after treatment:

Post assessment will be done after 60^th day on the basis of MASI score.

CONCOMITANT TREATMENT: (if any) –NA

 RESCUE MEDICATIONS: Sphatika Bhasma, + Lodhra Churna / Yastimadhu Churna

 INVESTIGATIONS:

Investigations will be performed in Group A only before the Jalaukavacharana to rule out any systematic illness / bleeding disorders:

 ASSESSMENT CRITERIA: MASI Score

Forehead =                 30%

Left malar=               30%

Right malar =                30%

Chin=                         10%

Total =                        100%

MASI=0.3A (D+H) +0.3A(D+H) +0.3A(D+H) +0.1A(D+H)

Varna Prasadana (Change in texture, lustre of skin)

 STASTICAL ANALYSIS:

The collected data will be analysed statistically using appropriate test.

 Descriptive statistics: The information that is collected will be represented using mean, median, standard deviation, standard error and observations will be represented using Graphs and Tabular columns.

 Inferential statistics:

 For Intra group-Wilcoxon’s signed rank test

 For Inter group-Mann Whitney’s U test

DECLARATION:

 Enrolment of the patients for clinical trial will be started only after approval of ethics committee and registration of clinical trial with CTRI (Clinical Trial Registry of India). Any adverse drugs events/ reaction observed throughout the study period will be reported to Pharmacovigilance cell of National Institute of Ayurveda, Deemed to be University, Jaipur.