Study the Effect of Ipomea carnea Jacq. Patra swarasa (Leaves Juice) in Treatment of Indralupta (Alopecia Areata): A Pilot Study

Introduction: Hair and skin disease create negative impact on individuals. Although such diseases doesn’t have any life threatening effects like systemic diseases still have much more importance as the cosmetic issue concern. Indralupta is a rare entity found in both male, and female at any age which can be correlated with 1-6, the spot where hairs are lost for 15 days at morning before bath. 10 objects will be selected from kaychikitsa OPD randomly and consider for study after their willingness and consent. Outcomes will be assessed with the help of different criteria according to hair texture, Hair fall and scalp area examination. Result: Result will be observed according to criteria and Wilcoxon signed rank test will be a applied. Conclusion: Ipomea carnea will be effective in Indralupta(Alopecia areata) .


INTRODUCTION
According to Ayurveda each dravya (material) in this universe is a medicine when it is used in proper manner [1]. Many plants are being used traditionally for treating various diseases but not mentioned in classical text. Ipomoea carnea jacq. is an example of same and are being used by traditional healers of Melghat area of Maharashtra to treat "chai" i.e. a condition in which a patch or many patches or total hairs on scalp are falling out and area of scalp became hairless (bald). The similar disease presentation mention in Ayurved under the name of Indralupta. It symptomatically can be correlated to Alopecia Areata [2]. Alopecia Areata is hypothesized to be an organ specific autoimmune disease mediated by T lymphocytes directed to the hair follicles and of unknown aetiology [3].
There are abundance of therapeutic modalities are available in Ayurveda and modern system of medicine. In Ayurveda, both shodhana (Internal and external cleansing procedures) and shamana treatment (Disease specific internal medications) are prescribed for Indralupta [4]. Some of the medicinal plants are effective but induces erosion and blisters; although these side effects are mild, non-serious and can subsides with proper treatment within 2-3 days [5,6]. In modern system of medicine use of systemic as well as local steroid is preferred the important component of treatment in alopecia areata with reported adverse effect. Also few other medicines with the steroid included in treatment which has limitation and not advisable for long term use and few surgical interventions with limited involvement which are costly and it has common surgical risks [7,8].
Ipomoea carnia jacq, belongs to convolvulaceae family found everywhere in India which is native of tropical America [9] and the main character of the plant is that it can regenerate very fast from its part in dry as well as the moist surfaces. Due to this unique character this plant is locally termed as thethar or besharam. The unique property of the plant is that this can survive well in terrestrial surface as well as can tolerate the waterlogged region or even water bodies [10,11,12]. I. carnea is used in leukoderma and other related skin diseases [13,14]. Formulated gel was found safe in skin irritation test [15]. It is taken for study after reviewing the data from various researches and the study has started which is based on a strong folklore claim from ethanomedicinal use of leaf juice (Patra swarasa) in Indralupta.

RATIONALE OF STUDY
Hair disorders cause negative impact towards the individual and his/her quality of life. Indralupta is included in Kshudraroga in Ayurveda characterised by hair loss. Although there are variety of treatments available in Ayurveda and modern science either they have some adverse effects or cost issue. Ipomoea carnia jacq is easily available plant and have reported effective in various diseases including. Traditionally being used in folklore medicine and found efficiently effective in indralupta. Degeneration of hairs is the main concern in indralupta and the regenerative property of Ipocarnia carnea might have effective in this condition. There is no skin eruption noted with the use of leaf juice (patra swaras). Hence the present study is taken with the view of minimal intervention, cost effectiveness, least or no adverse effect and to introduce Ipomoea carnea in Indralupta (Alopecia Areata).

Aim
Study the efficacy of Ipomoea carnea patra swaras (leaf juice) local application on indralupta (Alopecia areata)

Objectives
1. To study the effect of Ipomoea carnea leaf swarasa on indralupta. 2. To assess any ADR.

Case definition
A diagnosed Indralupta subject with symptoms patchy hair loss in single or multiple patches.

Research Question
Whether Ipomoea carnea is effective in management of Indralupta (Alopecia areata)?

Hypothesis
Ipomoea carnea is effective in management of Indralupta (Alopecia areata).

Null Hypothesis
Ipomoea carnea is not effective in management of Indralupta (Alopecia areata).

Inclusion criteria
a) Diagnosed patients of Indralupta (Alopecia areata) showing clinical findings as oval or round, well circumscribed, bald patch (having diameter less than or equal to 3 cms). b) Patients of either sex of age 15 yrs to 55yrs. C) Patient will be included with written consent only.

Exclusion criteria
a) Patient with more than 3 bald patches. b) Patient with any other skin diseases. c) Patient with systemic disease.

Criteria for discontinuing or modifying allocated interventions
Subject will be withdrawn from the study if any untoward incidence, features of drug sensitivity or any other disease or problem arises, the subject will be offered free treatment till the problem subsides.

Sample size-10
Groups-Single group (Before and after treatment) Study design-Single armed study.

Study type-Intervention
Intervention -Patra swarsas (Leaf juice) of I. carnia for local application.
Posology-Q.S., at morning time, after bath at in the morning.
Skin irritation test-I. carnea swarasa will be apply on the skin covering 0.5 cm area of dorsal aspect of forearm observe half hour for any skin irritation, redness or any other reaction.

Assessment criteria [16]
A. To assess the effect of therapy, subjective symptoms criteria like hair texture, hair fall and hair loss (Table A1, A2 & for gradation of patches  table A3) will be considered.  3. Images of the patients were taken before and after the trial and used for analysis.

Statistical tests
Wilcoxon signed rank test.

Withdrawal criteria
If any type of side effect were observed during study.
If aggravation of symptoms occurred.
If patient is not willing to continue the treatment.

Dissemination policy
The information will be dispersed by paper distribution, Personal visit and through multimedia. Creation qualification rules and any proposed utilization of expert scholars.

RESULTS AND DISCUSSION
Ipomoea carnea is a tropical shrub does not mentioned in any classical text Ayurveda; but it is used by traditional healers since long ago claiming effective in Indralupta disease. Indralupta (Alopecia Areata) is categorised in Kshudra roga is a type of Skin disease characterised by hair loss in specific manner. Local application of medicine in skin diseases serves important and effective role. Here, folklore claim is about the same mode of application and found actual in the field survey.

STRENGTH
More of the effective treatment modalities in the Indralupta(Alopecia Areata) are mainly tropical administrations. In present study same modality is being used which will hopefully give positive result.

CONCLUSION
Ipomoea carnia leaf juice application is very easy mode of treatment and the plant is abundantly available in field. Positive results will be more helpful than current treatment scenario in the management of Idralupta (Alopecia Areata).

LIMITATION
The plant material is not from classical literature and such studies are not conducted earlier hence it is taken as a pilot study and it is being conducted with minimal sample size.

ETHICAL APPROVAL
The present study has approved by Institutional

CONSENT
The consent has taken from the patient before starting the assessment. During the investigation the classification of every patient will be kept up. With all the data model assent structure and other related documentation has given to members in the language the individual understand.