| CTRI Number |
CTRI/2020/06/025982 [Registered on: 19/06/2020] Trial Registered Prospectively |
| Last Modified On: |
14/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
effectiveness of Pama-Dadru-Vicharchikahar lepa (1) in Vicharchika (Eczema) |
|
Scientific Title of Study
|
Randomised controlled clinical study to evaluate the efficacy of pama-dadru-vicharchikahar lepa (1) topically in the management of vicharchika(Eczema). |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amol Mungle |
| Designation |
PG Scholar |
| Affiliation |
DMM Ayurved College Yavatmal |
| Address |
22 Near shankar mandir Parda Ta Samudrapur Dist Wardha
DMM ayurved college Shivaji nagar Arni road Yavatmal.
Yavatmal
MAHARASHTRA
442305
India |
| Phone |
9545998766 |
| Fax |
|
| Email |
amolmungale31@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suryaparakash Jaiswal |
| Designation |
Professor & HOD kayachikitsa department |
| Affiliation |
DMM Ayurved College Yavatmal |
| Address |
Navbharat 40 Rathod layout Nandanwan nagar near kantanand bhavan yavatmal
Navbharat 40 Rathod layout Nandanwan nagar near kantanand bhavan yavatmal
Yavatmal
MAHARASHTRA
445002
India |
| Phone |
9822126706 |
| Fax |
|
| Email |
dr.skjaiswal01@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suryaparakash Jaiswal |
| Designation |
Professor & HOD |
| Affiliation |
DMM Ayurved College Yavatmal |
| Address |
DMM Ayurved College Yavatmal Shivaji nagar Arni road Yavatmal
Shivaji nagar Arni road Yavatmal
Yavatmal
MAHARASHTRA
445002
India |
| Phone |
9822126706 |
| Fax |
|
| Email |
dr.skjaiswal01@gmail.com |
|
|
Source of Monetary or Material Support
|
| DMM Ayurved College Yavatmal |
|
|
Primary Sponsor
|
| Name |
DMM Ayurved College Yavatmal |
| Address |
Shivaji nagar Arni road Yavatmal |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Amol Mungle |
DMM Ayurved College Yavatmal |
Shivaji nagar Arni road Yavatmal
Yavatmal
MAHARASHTRA |
9545998766
amolmungale31@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L239||Allergic contact dermatitis, unspecified cause, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Mometasone Furoate 0.1% ointment |
Mometasone Furoate 0.1% ointment Topical application for twice a day for 6 weeks |
| Intervention |
Pama-Dadru-Vicharchikahar Lepa (1) |
Pama-Dadru-Vicharchikahar Lepa (1) Local application for twice a day for 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
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.
7) Patient having controlled thyroid
8) Patient having controlled HTN |
|
| ExclusionCriteria |
| Details |
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
17
7.6
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.
10) Psoriasis, Pulmonary tuberculosis. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the therapeutic effect of Pama-Dadru-Vicharchikaha lepa(1) compare to Mometasone Furoate (0.1%) in the management of vicharchika. |
7th 14th 21th 28th 35th 45th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To study the disease Vicharchika and Eczema .
2) To see the effect of Pama-Dadru-Vicharchikahar lepa (1) 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 see the effect of Mometasone Furoate 0.1% ointment in Vicharchika . |
7th 14th 21th 28th 35th 45th day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/07/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
INTRODUCTION:In Ayurveda, all skin disorders describes under the heading of ‘kushtha‘. Which have been classified mainly into two groups- Viz. Mahakushtha Kshudrakushtha[3,4] च.नन.५/४ Vicharchika being one among kshudrakushtha. All kushthas having tridoshaj origin,[5] hence vicharchika can be explained in similar manner i.e Kapha is responsible for Kandu, Pitta is responsible for Strava and Shyava indicate the presence of Vata. Even with its Tridoshaj origion , various Acharyas have mentioned different dominances in Vicharchika i.e. Kapha, Pitta, Kapha-Vata pradhana 2 which also suggest specific symptoms complexes. The incidence rate of vicharchika is 15% to 20%[14] in India as per WHO and is seen among the people of every age group. As per the symptoms and pathogenesis, Vicharchika has been directly associated with Eczema (dermatitis) in modern science, with symptoms Kandu ( itching), Pidaka (eruptions), Shyava (blackish discolouration), Bahustrava ( discharge,oozing), Raji ( marked lining due to thickening of skin lesion), Arti (pain), Ruksha (dryness).[6,7,8,9] 3 Eczema is broad term used for many types of skin inflammations, usually first symptom of eczema is intense itching, the rash appears later and is red in nature has a eruptions of different sizes ,for this reason ,Eczema is also called as “itch that rashes.
OBJECTIVE: PRIMARY OBJECTIVE: To study the therapeutic effect of Pama-Dadru-Vicharchikaha lepa(1) compare to Mometasone Furoate (0.1%) in the management of vicharchika. 1) To study the disease Vicharchika and Eczema .
SECONDARY: 2) To see the effect of Pama-Dadru-Vicharchikahar lepa (1) 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 see the effect of Mometasone Furoate 0.1% ointment in Vicharchika . 12 4) To compare the effect of Pama-Dadru-Vicharchikhar lepa (1) with Mometasone Furoate 0.1% ointment in the management of Vicharchika. 5) Pathological measurable criteria is not applicable. 6) Affected area of the patients body will be measure.
METHODOLOGY: Type of Study Design: Randomized controlled study, Single Blind, Double Arm, INTERVENTIONAL, comparative STUDY.
SAMPLE SIZE : 60 patients (30 in each group)
GROUPING AND DRUG DELIVERY REGIMEN: Group A : Pama-Dadru-Vicharchikahar lepa (1) Local application for twice a day for 6 weeks Group B: Mometasone Furoate 0.1% ointment Topical application for twice a day for 6 weeks
Age group: 17 - 70 yrs
Followup : 45 days |