Effectiveness of Bakuchikadyam Choorna orally and Manashiladi tailam topically in the management of Vicharchika(Eczema)

Phase 2/3

Not yet recruiting

• Conditions: Other atopic dermatitis,

• Registration Number: CTRI/2020/10/028366
• Lead Sponsor: DMM Ayurved Mahavidyalaya Yavatmal

Brief Summary

Introduction

Skin is the largest and important organ and outermost covering of the body which acts as a protective barrier.But very often, it is exposed to many entities which can damage it and cause many of the skin disorder. About 10-20% of the general practice includes the patients suffering from skin disorder and Eczema accounts for a very large proportion of all the skin diseases

In Ayurveda, The word Kushta is broad term, which covers almost all skin disorders.

“kushnatee iti kushthamâ€

(Ma.Ni./Kushta./Tika 1)

According to Astang hrudaya,in kushta due to vitiated dosha the part of skin becomes affected and changes its normal colour called kushtha.

Which have been classified mainly into two groups-

Viz.

(1) Mahakushtha (2) Kshudrakushtha

Vicharchika being one among kshudrakushtha,is also a Rasa,Rakta and Mansa dhatu pradoshaj vikara

 According to charak samhita,vicharchika is kaphapradhan vyadhi.[6] and symptoms of vicharchika are kandu(Itching), shyava varna(blackish discolouration), pidika(eruption), bahustrava(discharge), ruja (pain), rajyo (marked lining due to thickness of lesion ), rukshata(dryness),lohit varna(redness of lesion).[5,6,10]

Also Many Acharya defined as various dosha responsible for Vicharchika vyadhi and defined vicharchika is kaphapradhan, pittapradhan, Kaphavatpradhan Disease.

purpose of study:- To study the therapeutic effect of oral administration of Bakuchikadyam choorna and topical application of Manashiladi tailam.

OBJECTIVE:

PRIMARY OBJECTIVE: To study the therapeutic effect of oral administration of Bakuchikadyam choorna and topical application of Manashiladi tailam.

 SECONDARY OBJECTIVE: 1) To study the disease Vicharchika and Eczema .

 2)To see the effect of Bakuchikadyam choorna and Manashiladi tailam in signs and symptoms of vicharchika i.e

1)Kandu

2)Shyava varna

3)Pidika

4)Bahu strava

5)Ruja

6)Rajyo

7)Rukshata

8)Lohit varna

 3) To compare the effect of Bakuchikadyam choorna and Manashiladi tailam with Aarogyavardhini gutika and Karanjadi tailam in the management of Vicharchika.

 Point for RCT :-

1) Randomized proposed

Simple randomized control trial

2) Allocation concealment proposed:-

Patient will be randomly allocated in intervention group with the help of Lottory method.

3)Blinding proposed :- Not applicable .

 Sample size :- 60 patients

30 patients in each group

1) 30 patients in intervention group.(Group –A)

2) 30 patients in controlled group.(Group – B)

 GROUPING AND DRUG DELIVERY REGIMEN:

Group-A (Trial group)- Bakuchikadyam choorna 3gm orally twice a day  and Manashiladi tailam local application twice a day for 45 days

Group-B (Control group)- Aarogyavardhini gutika 250mg orally twice a day and Karanjadi tailam  local application twice a day for 45 days

 Time for drug administration :- 45 days

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-09-10
• Study Start: 2020-10-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 1. Age group above 16 and below 70 years.
• 2. patient having classical signs and symptoms of vicharchika, a) Kandu (itching) b) Pidika (eruption) c) Syava varna (blackish discolouration) d) Strava (discharge) e) Ruja (pain) f) Rajyo (marked lining due to thickness of lesion) g) Rukshata(dryness) h) lohit varna (redness of lesion ) 3) Patient willing for clinical trial.
• 4. Irrespective of gender, occupation, Religion, economical barrier.
• 5. patients willing to participate.
• 6. patients who will fulfil criteria and take regular medicines with regular follow up.

Exclusion Criteria

• 1. Age group below 16 years and above 70 years .
• 2. Pregnant and lactating mother.
• 3. Infective origins like a)Koch‘s b) Hansen‘s disease c) Scabies d) Fungal infection /herpes zoster.
• 4. Drug induced eczema.
• 5. Immune compromised like HIV,HBV 6) Systemic disorders DM,CVV 7) Diabetic wound 8) Renal diseases like CKD 9) Endocrine disorders will exclude from study to avoid over lapping of symptoms.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To study the therapeutic effect of oral administration of Bakuchikadyam Choorna and topical application of Manashiladi tailam.	7th 14th 21th 28th 35th 45th day

Secondary Outcome Measures

Name	Time	Method
1) To study the disease Vicharchika and Eczema	2) To see the effect of

Trial Locations

Locations (1)

DMM Ayurved Mahavidyalaya Yavatmal; 🇮🇳 Yavatmal, MAHARASHTRA, India

DMM Ayurved Mahavidyalaya Yavatmal

🇮🇳Yavatmal, MAHARASHTRA, India

Dr pravin kendre

Principal investigator

8805324142

pravinkendre5@gmail.com