| CTRI Number |
CTRI/2023/07/054863 [Registered on: 06/07/2023] Trial Registered Prospectively |
| Last Modified On: |
01/05/2024 |
| 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
|
Efficacy of Navaka Kashaya and Manjisthadi Tail in the management of dry eczema. |
|
Scientific Title of Study
|
A randomised controlled clinical trial on efficacy of Navaka Kashaya and Manjisthadi Tail in the management of Vicharchika with special reference to dry 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 Puja Agarwal |
| Designation |
MD Scholar Department Of Kayachikitsa. |
| Affiliation |
National Institute Of Ayurveda(De-Novo) |
| Address |
Department of Kayachikitsa National Institute of Ayurveda Deemed to be university Jaipur
Jaipur RAJASTHAN 302002 India |
| Phone |
9587848547 |
| Fax |
|
| Email |
agarwalpuja2394@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Prof H M L Meena |
| Designation |
Professor |
| Affiliation |
National Institute of Ayurveda Deemed to be University |
| Address |
Department of Kayachikitsa National Institute of Ayurveda Deemed to be University Jaipur
Jaipur RAJASTHAN 302002 India |
| Phone |
9461297017 |
| Fax |
|
| Email |
hari_mohan68@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Puja Agarwal |
| Designation |
MD Scholar Department Of Kayachikitsa |
| Affiliation |
National Institute Of Ayurveda(DE NOVO) |
| Address |
Department of Kayachikitsa National Institute of Ayurveda Deemed to be University Jaipur
Jaipur RAJASTHAN 302002 India |
| Phone |
9587848547 |
| Fax |
|
| Email |
agarwalpuja2394@gmail.com |
|
|
Source of Monetary or Material Support
|
| NATIONAL INSTITUTE OF AYURVEDA DEEMED TO BE UNIVERSITY JAIPUR RAJASTHAN |
|
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Primary Sponsor
|
| Name |
NATIONAL INSTITUTE OF AYURVEDA DEEMED TO BE UNIVERSITY |
| Address |
NATIONAL INSTITUTE OF AYURVEDA DEEMED TO BE UNIVERSITY NEAR JORAWER SINGH GATE AMER ROAD JAIPUR RAJASTHAN |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Puja Agarwal |
National Institute of Ayurveda hospital |
Room no 1,7,18,22,25., Department of Kayachikitsa National Institute of Ayurveda Deemed to be University jorawar singh gate amer road Jaipur Rajasthan
Jaipur RAJASTHAN |
9587848547
agarwalpuja2394@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Of National Institute of Ayurveda Deemed to be University Jaipur Rajasthan |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L209||Atopic dermatitis, unspecified. Ayurveda Condition: VICARCIKA, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Navaka Kshaya, Reference: chakradutt-kushtha chikitsa(50/58), Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 6 Weeks, anupAna/sahapAna: No, Additional Information: Nil(2) Medicine Name: Manjisthadi Taila, Reference: Yogratnakar Kushthachikitsa-tailrogadhikar-1, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 6 Weeks, anupAna/sahapAna: No, Additional Information: DOse may be adjusted as per the size of lesion | | 2 | Comparator Arm (Non Ayurveda) | | - | 1.Betamethsone 0.1% and 2.Tab Hydroxyzine | 1. Dose- according to the size of lesion
dose form- cream base
route of administration-Local Application
Time of administration- Twice a day
Duration - 6 weeks
2.Dose- 25mg
dose form- Tablet
route of administration-Oral
Time of administration- SOS
Duration - 6 weeks
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients age between 18-60 years
Patients of either sex
Patients having any signs and symptoms of Vicharchika (Eczema) like Vaivarnyata (Discolouration) Rukshata (Dryness) Kandu (pruritis) Rajii (Thickening of skin)
Patients having chronicity less than 5 years |
|
| ExclusionCriteria |
| Details |
Patients with Steroid and cytotoxic treatment(>5 years).
Patient having concomitant illness( like-HIV, Malignancy, any immuno-compromised state.)
patient having associated skin disease like-vitiligo, psoriasis etc.)
Pregnant or lactating women
Patient participated in any clinical trial for last 6 months.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in the EASI Score |
42 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in Sign and Symptoms of Vicharchika with special reference to Dry Eczema and Change in the Extent of impairment in QoL by using DLQI(Dermatology Life Quality Index).
|
Baseline and 42 days after treatment. |
|
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Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
01/08/2023 |
| 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="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
INTRODUCTION In Ayurveda,
various skin diseases have been described under the term Kushtha. Vicharchika
is a type of kshudrakushtha ,characterized by skin eruption with
dark discoloration, itching and profuse discharge, being involved of three
doshas with the dominance of kapha acc to Acharya charak. Authors like Vagabhatta, Madhavakara and Bhavamishra do agree with him whereas Sushruta,
‘the father of surgery’ has mentioned
the symptoms as dryness of the skin with intensive itching and marked
thickening of skin, with the dominance of pitta. Similarly difference of
opinion exists between the other texts like Kashyapa, Harita, Bhela etc, However All
the authors have concluded with the fact that itching and eruption are cardinal symptoms.
Vicharchika
has been included under raktapradoshaja vikara.
Being a type of kustha, recurrence & chronic course is common. It is
skin disease with predominance of kapha with clinical features like kandu,
srava, pidika, shyavata, rookshata, raji, ruja
and daha mainly in extremities. It has social impact, affects
psychological status and disturb the social life due to its appearance, severe
itching disturbing the routine. NEED OF STUDY In maximum of cases, patients
come to ayurveda treatment after not getting satisfactory cure from modern medicine, naturally by the time the disease has attend the
chronic state , hence it is the need of the hour to find out safe and
effective medicine for Vicharchika on a long term and here comes the role of
Ayurveda.
To overcome the problem of
high rate of recurrence, this trial drug
has been selected which is effective in destroying all types of kushtha
as mentioned in the phalashruti of trial drugs .These drugs helps to
destroy the samprapti of vicharchika (Eczema) due to its ushna
virya and katu-kashaya rasa
and enchances the cure rate to the patient of vicharchika and check its
recurrence. AIM: To evaluate and compare the efficacy of “Navaka Kashaya & Manjisthadi
Tail†in the management of Vicharchika w.s.r. to Dry eczema with
Standard Control Drugs (Betamethasone oint. & Tab Hydroxyzine).
OBJECTIVE · Evaluation and comparison
of effect of trial drugs on signs and
symptoms of Vicharchika with special reference to Dry Eczema. · Evaluation and comparison
of effect of trial drugs on EASI Score.
· Evaluation and comparison
of effect of trial drugs on Extent of
impairment in QoL by using DLQI(Dermatology Life Quality Index) RESEARCH QUESTION
Is there any difference in
effect between the trial drugs and standard control drugs in the management of
Vicharchika with special reference to Dry Eczema? HYPOTHESIS
Null Hypothesis (H0):
There is
no difference between the effect of
Trial drug (“Navaka Kashaya and Manjisthadi Tailâ€) and standard control
drug(Betamethasone oint. & Tab Hydroxyzine) in the management of
Vicharchika w.s.r to Dry Eczema.
Alternative Hypothesis:
(H1): There is
difference between the effect of trial drug( “Navaka Kashaya and Manjisthadi
Tailâ€) and standard control drug (Betamethasone
oint. &tab Hydroxyzine) in the
management of Vicharchika w.s.r. to Dry Eczema.
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