Randomised open controlled clinical study to evaluate the efficacy of Gunja-Chitraktwak lepa for external use along with Dhatryadi kwath for internal use in Shvitra vyadhi

1) Title of study: Randomized open controlled clinical study to evaluate the efficacy of Gunja-Chitraktwak lepa for External use along with Dhatryadi kwath for Internal use in Shvitra vyadhi.

2) Study Objective: Primary Objective- To study the efficacy of GUNJA-CHITRAKTWAK LEPA and DHATRYADI KWATH in Shvitra.

Secondary Objectives- 1. To study the effect of GUNJA-CHITRAKTWAK LEPA for External applicaion and DHATRYADI KWATH for Internal use in signs and

symptoms like colour of patch, exudation, itching, burning sensation, snigdhatva or rukshatva, parushya, loss of hair follicles, size of patch, etc.

2. To study etiopathology of Shvitra in detail.

3. To assess various causes responsible for Shvitra in study population as well as according to review.

4. To achieve the outcome of study in 90 days.

3) Study design: Type of study- Randomized open controlled, parallel

Method of Randomization- Lottery method

Screening of patients in study population

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Inclusion criteria                           Exclusion criteria

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Informed and written consent                        Excluded

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Divided in two groups Group A and Group B (by Lottery method)

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Trial Group (GROUP A)                                               Control Group (GROUP B)

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Gunja-Chitraktwak lepa and Dhatryadi kwath           Kakodumbaradi lepa and Dhatryadi kwath

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Initial assessment

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Dietary modification adviced to all

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Assessment of subjective and objective parameters on 30th, 60th and 90th Day

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Data collection

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Statistical analysis of data

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Discussion, Results, Conclusion and Summary of Study

4**) Study Population:** The regular and camp patients coming to OPD of Kayachikitsa Department.

Patients having Shvitra of age group- 16 years to 60 years irrespective of gender.

Time of study per patient- 90 days

Follow up on 30th, 60th and 90th day.

Inclusion Criteria- 1. Patients having Signs and Symptoms of Shvitra.

2. Age group between 16-60 years

3. Chronicity less than 1 year

Exclusion Criteria- 1. Patients not fulfilling the above criteria

2. All that Shvitra having Asadhya lakshana as per mentioned in Ayurvedic texts like Varshaganotpannam, Agnidagdhaj.

3. H/o Chronic illness like Diabetes Mellitus, Atopic dermatitis, other serious systemic illness.

4. Gravid and lactating women.

5. Lesions at Guhyanga (genital organ), Panipadatala (palms and soles), oshtha (lips), Ekanga (involving an entire organ), Sarvanga (generalized lesion)

6. Patches with Raktaroma (reddish hair), and Samsakta (coalescent)

5) Intervention: Intervention drug: Gunja-Chitraktwak lepa along with Dhatryadi kwath.

6) Control group drug: Kakodumbaradi lepa and Dhatryadi kwath.

7) Treatment details:

GroupsTrial groupControl group
No. of subjects 15 15
Drug Gunja-Chitraktwak lepa Dhatryadi kwath Kakodumbaradi lepa Dhatryadi kwath
Time Twice in a day Twice in a day Twice in a day Twice in a day
Application time Until the lepa gets dry (20 min) Until the lepa gets dry (20 min)
Quantity 1 gm 40 ml 1 gm 40 ml
Total duration 90 days 90 days 90 days 90 days
Route of administration Local application Oral Local application Oral
Follow up On 30th, 60th, 90th day On 30th, 60th, 90th  Parisravi (discharge)

8) Assessment criteria:

Subjective parameters- Parisravi (discharge)

Kandu (itching)

Daha (burning sensation)

Rukshatva (dryness)

Romadhvansi (loss of hair follicles)

Objective parameters- Number of mandala

Size of mandala

Colour of patches

Chronicy of patches

9) Total effect of therapy:

Effect of therapy****Percentage of improvement
Cured 100%
Marked improvement 75% and above relief in signs and symptoms
Moderate improvement >50% to <75% relief in signs and symptoms
Mild improvement >25% to <50% relief in signs and symptoms
Unchanged <25% relief in signs and symptoms

10) Location: OPD no. 17 Kayachikitsa Department, Yashwant Ayurved College PG teaching and RC, Kodoli, Kolhapur, Maharashtra, 416114