AN OPEN LABELLED RANDOMISED COMPARATIVE CLINICAL STUDY TO ASSESS THE EFFICACY OF PATHA (Cissampelos pareira Linn) PATRA LEPA AND PATHA PATRA AVACHURNANA IN THE MANAGEMENT OF DADRU KUSHTA VIS-A-VIS TINEA CRURIS

NEED FOR THE STUDY

Skin is the largest organ of the integumentary system and outer covering of the body. Skin is a mirror that reflects exteral and internal pathology there by helps in diagnosis of disease. Now in a time when looking good has become very important to most people, its a very  significant aspect to maintain skin healthy. Skin diseases accounts for prevalance rate 10-15% of all consultation in general practice.Skin diseases have been comprehended under the heading of kushta in Ayurveda and we find a vivid description of Dadru kushta, since Samhita period. Acharya Charaka has mentioned 18 types of kushta which are further subdivided into Mahakushta and Kshudra kushta. Dadru kushta has been mentioned under kshudra kushta in Charaka samhita chikitsa sthana. Acharya Vriddha Vagbhata has mentioned 18 types of kushta and mentiones that dadru kushta is kaphapittaja variety of kushta.Acharya laghuvagbhata has also followed same classification as that of acharya Susrutha. Dadru may be diagnosed with symptoms such as severe itching(kandu), erythema(raaga), burning sensation(daha) and discoid lesions(pidaka), with elevated borders(utssanamandal). Dadru is a type of kushta and analogues with “Dermatophytosis” or fungal infection or   Tinea(Ringworm) infection in contemporary science. Dadru comes under “SUPERFICIAL FUNGAL INFECTION OF SKIN”, most common dermatological problem affecting children, adolescents and adults affecting upto 15% of world’s population. In India 5 out of 1000 people suffer from Tinea Infections. It can cause an itchy, red, circular rash. Commonly infection types are named with respect to affected body parts. Fungal infection of groin, perineal, pubic, perianal skin together known as ‘Tinea Cruris’ or Jock itch affect 20-25 % of world’s population. Developing and tropical countries have an increased prevalance of dermatophytic infections secondary to high temperatures and increases humidity. Adolescent and adult males comprise the majority of patients seen for Tinea cruris. Treatment of cutaneous dermatophytosis has increasingly become difficult and it depends upon severity of infection rate. In this condition drugs which are capable of supressing kapha dosha, which are having tikta, katu rasa, usna properties, kanduhara, krimighna and kushtaghna are beneficial. Here ‘Patha’ patra choorna is applied externally along with gomutra which acts locally over the lesion reducing itching, redness and pidakas in one group and Patha patra avachurnana‘dusting’ is done in another group. Patha is having tikta, katu rasa which helps in mitigation of kapha dosha, usna virya and it has krimighna and Kanduhara karma. Patha(laghupatha) grows as a herb in many regions and is is also cost-effective drug. So, an attempt is made to establish the efficacy of Patha patra lepa and patha patra avachurnana(dusting) in Management of Dadru kushta vis-a-vis  Tinea Cruris. Hence the present study entitled.

NULL HYPOTHESIS:H****0

· Patha patra lepa has no effect in the management of Dadru kushta vis-a-vis Tinea cruris.

· Patha patra avachurnana has no effect in the management of Dadru kushta vis-a-vis Tinea cruris.

ALTERNATE HYPOTHESIS:(H1)

· Patha patra lepa has effect in the management of Dadru kushta vis-a-vis Tinea cruris.

· Patha patra avachurnana has effect in the management of Dadru kushta vis-a-vis Tinea cruris.

REVIEW OF LITERATURE:

AYURVEDIC:

Detailed review of Dadru kushta will be done from Bruhatrayi, laghutrayi, nighantus and all other relevant ayurvedic textbooks with commentators opinion, websites, published journals.

MODERN :

Detailed review of Tinea cruris will be done from all available classical modern textbook of medicine and other relevant books, websites, published journals.

DRUG REVIEW:

The description and properties of Patha patra is explained in various texts as follows:

Patha will be reviewed from bruhatrayi, laghutrayi, all available nighantus, textbooks, journals, articles, websites.

Detailed review of Cissampelos pareira will be done from Indian Medicinal Plants,  Medicinal Plants of India and other relevant textbooks.

Sl. no

Drug name

Botanical name

Family

Part used

Rasa

Virya

|1

Laghu Patha

Cissampelos pareira

Menispermaceae

Leaves

Tikta, Katu

Usna

PREVIOUS WORK DONE:

No previous work has been noticed on Patha patra in Dadru kushta with special   reference to  Tinea cruris.

Verma Annu - Dadru kushta(Dermatophytosis) : An ayurvedic literature review (Haridwar,2021) Vol:7.

Gaurav mahant – Comparative Clinical study to evaluate efficacy of lakshadi lepa and durvadi lepa in management of Dadru(Tinea corporis), Ghataprabha 2019 Vol:7.

Sourabh Deshmukh – A Clinical study of Edagajadi lepa in the management of Dadru kushta, (Maharashtra, 2015) Vol:3.

AIM OF THE STUDY:

To compare the efficacy of Patha patra as a Bahirparimarjana chikitsa in different forms in the management of Dadru kushta(Tinea cruris).

OBJECTIVES OF THE STUDY:

To study the preliminary Pharmacognostic and Phytochemical analysis of Patha patra.

To assess the efficacy of Patha patra lepa in the management of Dadru kushta(Tinea cruris).

To assess the efficacy of Patha patra avachurnana(dusting) in the management of Dadru kushta(Tinea cruris).

To compare the effect of Patha patra lepa over Patha patra avachurnana (dusting) in the management of Dadru kushta(Tinea cruris).

MATERIALS AND METHODS:

Source of data:

LITERARY SOURCES:

The literary data will be collected from Central Library as well as Dravyaguna department of Taranath Government Ayurvedic Medical College and Hospital Ballari.

The data also collected from journals periodicals and other published works and even from internet sources.

CLINICAL SOURCES:

40 subjects of Tinea cruris will be randomly selected from OPD and IPD of Taranath Government Ayurvedic Medical College and Hospital Ballari.

DRUG SOURCES:

Raw drugs will be collected from its natural habitat under the guidance of faculties of Dravyaguna. The respective medicine will be prepared in Rasashala of RSBK department of Taranath Government Ayurvedic Medical College and Hospital Ballari.

METHOD OF COLLECTION OF DATA:

Literary Data

A proforma will be prepared with all points of history taking, physical signs and lab investigation. The parameters of signs and symptoms will be scored and will be analyzed by standard method and by using suitable statistical test.

Clinical Data

40 subjects diagnosed with Tinea cruris attending the OPD and IPD of Taranath Government Ayurvedic Medical College and Hospital Ballari will be screened under strict inclusion and exclusion criteria and grouped under two groups and screened under special case sheet proforma.

STUDY DESIGN

**STUDY TYPE :-**Randomised Prospective Open labelled Comparative Study

Estimated enrolment    :-  40 subjects

Intervention Model       :- Comparative

Allocation                    :-   Randomised

Masking                        :- Open

Primary Purpose           :- Treatment

Study Duration             :-  30 days

Follow up                      :-  10 days

DIAGNOSTIC CRITERIA:

Diagnosis will be done on the basis of local signs and symptoms of Dadru kushta(Tinea cruris). Subjects presenting with subjective parameters:

Kandu(itching)

Pidaka(eruption)

Raaga(erythema)

Daha(burning sensation)

Udgata mandala(elevated circular lesion)

Objective parameters :

Size of mandala

AEC

KOH MICROSCOPY

INCLUSION CRITERIA:

1. Subjects diagnosed as Dadru as per the clinical features like kandu, pidaka, mandala mentioned in Ayurvedic text will be included in the study.

2. Subjects who have signed informed consent form.

3. Age group above 18-60 years randomly included for study.

EXCLUSION CRITERIA:

1. Subjects having any acute and complex systemic illness.

2. Pregnant and lactating women will be excluded for the trial.

3. Subjects presenting with any other skin disorder which is associated with dadru kushta.

4. Subjects having immune compromising condition or taking immunosuppressive drugs.

WITHDRAWAL CRITERIA:

Patient can get withdraw from the trial anytime with following reasons or as the case may be

Health and safety issues

Personal reasons

Noncompliance

Lost to follow up

Randomization error

DROP OUTS

An attempt shall be made to record the reason for dropouts, if any during the clinical trial.

DRUG COMPLIANCE

If there is more than or equal to 80% compliance, the participant would be continued in the trial. The compliance needs to be assessed at each visit during the follow up by counting the number of empty container / sachets returned and assessing the approximate quantity of medicine consumed by the patient.

CONCOMITANT MEDICATION

A concomitant medication (con-med) is a drug or biological product, other than study drug, taken by a subject during a clinical trial.

Details of concurrent illness / medications consumed by the participants registered under the trial will be recorded in case report form. The investigating physician will record any medication(s) he/ she may prescribe to alleviate their ailments.

RESCUE MEDICATION FOR INTERCURRENT ILLNESS:

A medication intended to relieve symptoms immediately. This is in contrast to preventive medications, which are taken over a long period of time to prevent or manage symptoms. To alleviate any emergency, the use of rescue medication is permitted as per the wisdom / discretion of the principal investigator. However, the same will be documented in appropriate column in the Case Record Form.

INTERVENTION:

GROUP A- 20 PATIENTS

GROUP

n =

(no of patients)

DRUG

DOSAGE

DURATION

|A

20

External application of patha patra lepa

Quantity   sufficient

30 consecutive days

Prepared lepa of patha patra with sufficient quantity of gomutra is to be applied on affected areas.

Lepa to be removed before drying completely.

Thickness – Angushtha 1/3rd (0.205 inch).

Applied two times a day(morning and evening, keeping a gap of 12 hours) after washing the affected areas.

GROUP B-  20 PATIENTS

GROUP

n =

(no of patients)

DRUG

DOSAGE

DURATION

|B

20

Patha patra  Avachurnana(dusting)

Quantity   sufficient

30 consecutive days

Dusting of sukshma churnaof Patha patrais done on affected lesions.

Applied two times a day (morning and evening, keeping a gap of 12 hours) after washing the affected areas.

PREPARATION OF THE MEDICINE:

Raw drug which is collected and dried under shade, should be collected and made churna by using pulverizer machine and then sieved through suitable number(120) sieving jar.

ASSESSMENT CRITERIA:

GRADING FOR SUBJECTIVE PARAMETERS:

SL NO

SYMPTOM

PARAMETERS

GRADE

|1.

Kandu (itching)

No itching

0

|  Mild /infrequent itching

1

|      Moderate/ frequent itching, compilsive scratching, do not disturb sleep

2

|          Severe itching/ very severe itching disturbing sleep and other activities

3

|2.

Pidaka (eruption)

No eruption/pidaka

0

|Pidaka in 0-25% affected, 1 to 3 mandal

1

|Pidaka in 25-50% affected, 4 to 6 mandal

2

|Pidaka in 50-75% affected, more than 6 mandal

3

|3.

Raaga (erythema)

Normal skin colour

0

|  Faint red colour

1

|  Red colour

2

|  Brownish red colour

3

|4.

Daha(burning sensation)

Absent

0

|  Mild burning sensation after itching

1

|  Moderate burning sensation(No disturbance in sleep)

2

|  Severe burning sensation(disrupts sleep)

3

GRADING FOR OBJECTIVE PARAMETERS:

SL NO

SYMPTOM

PARAMETERS

GRADE

|1.

Area of lesion

No mandala

0

|  < 5 cm

1

|  5-10 cm

2

|  >10 cm

3

|2.

AEC(absolute eosinophil count)

Normal (30-500 cells/ml)

0

|  Raised (>500 cells/ml)

1

|3.

KOH MICROSCOPY

Negative

0

|  Positive

1

DATA WILL BE COLLECTED AS FOLLOWS:

Pre-test Assessment on- 0th day     - BT

Mid-test Assessment- 15thday   - DT1

Post-test Assessment – 30th day     - AT

After 10 days Follow up – 40th day     - AF

OVERALL ASSESSMENT:

Very Good Improvement - >75%

Good Improvement - 51-74%.

Moderate Improvement - 26-50%

Mild Improvement - <25%

No relief - 00