CTRI Number |
CTRI/2022/05/042516 [Registered on: 12/05/2022] Trial Registered Prospectively |
Last Modified On: |
19/12/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda |
Study Design |
Single Arm Study |
Public Title of Study
|
A clinical study of two formulations, navakashaya and vidangadi lepa in patients with vicharchika(dermatitis). |
Scientific Title of Study
|
An open label, single arm clinical study to evaluate the combined effectiveness of navakashaya and vidangadi lepa in vicharchika (Dermatitis). |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Dija T Lawrence |
Designation |
PG Scholar |
Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan, Karnataka |
Address |
Department of Kayachikitsa
Sri Dharmasthala Manjunatheswara
College of Ayurveda and Hospital, BM Road, Thanniruhalla, Hassan-573201, Karnataka, India
Sri Dharmasthala Manjunatheswara
College of Ayurveda and Hospital, BM Road, Thanniruhalla, Hassan-573201, Karnataka, India
Hassan KARNATAKA 573201 India |
Phone |
8606822879 |
Fax |
|
Email |
lawrencedija8@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Girish K J |
Designation |
Professor |
Affiliation |
Sri Dharmasthala Manjunatheswara College of Ayurveda and hospital |
Address |
Department of Kayachikitsa
Sri Dharmasthala Manjunatheswara
College of Ayurveda and Hospital, BM Road, Thanniruhalla, Hassan-573201, Karnataka, India
Department of Kayachikitsa
Sri Dharmasthala Manjunatheswara
College of Ayurveda and Hospital, BM Road, Thanniruhalla, Hassan-573201, Karnataka, India
Hassan KARNATAKA 573201 India |
Phone |
9448646855 |
Fax |
|
Email |
girideepa@yahoo.co.in |
|
Details of Contact Person Public Query
|
Name |
Dr Girish K J |
Designation |
Professor |
Affiliation |
Sri Dharmasthala Manjunatheswara College of Ayurveda and hospital |
Address |
Department of kayachikitsa
Sri Dharmasthala Manjunatheswara
College of Ayurveda and Hospital,BM Road,Thanniruhalla, Hassan-573201,Karnataka,India
Department of kayachikitsa
Sri Dharmasthala Manjunatheswara
College of Ayurveda and Hospital,BM Road,Thanniruhalla, Hassan-573201,Karnataka,India Hassan KARNATAKA 573201 India |
Phone |
9448646855 |
Fax |
|
Email |
girideepa@yahoo.co.in |
|
Source of Monetary or Material Support
|
Sri Dharmasthala Manjunatheswara
College of Ayurveda and Hospital, BM Road, Thanniruhalla, Hassan-573201, Karnataka, India |
|
Primary Sponsor
|
Name |
Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital |
Address |
Sri Dharmasthala Manjunatheswara
College of Ayurveda and Hospital,BM Road,Thanniruhalla, Hassan-573201,Karnataka,India |
Type of Sponsor |
Private medical college |
|
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 Dija T Lawrence |
Sri Dharmasthala Manjunatheswara College Of Ayurveda And Hospital |
Sri Dharmasthala Manjunatheswara
College Of Ayurveda And Hospital, Hassan,Karnataka- 573201 Hassan KARNATAKA |
8606822879
lawrencedija8@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee Sri Dharmasthala Manjunatheswara College Of Ayurveda and Hospital, Hassan |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:L309||Dermatitis, unspecified. Ayurveda Condition: VICARCIKA, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: NAVAKASHAYA, Reference: CHAKRADATTA, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 45(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
1. Subjects suffering with Vicharchika up to 1 year of chronicity
2. Subjects of either gender, aged between 18-70 years
3. Subjects willing to participate in the study and ready to sign informed consent form |
|
ExclusionCriteria |
Details |
1. Subjects with uncontrolled diabetes mellitus
2. Pregnant and lactating women
3. Subjects with impaired cardiac, renal, and hepatic functions |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
1.Itching sensation ( Kandu)
2.Blackish brown discoloration (Shyava Varna)
3.Papule (Pidaka)
4. Excessive exudation (Bahu Srava )
EASI scale |
30 days |
|
Secondary Outcome
|
Outcome |
TimePoints |
QUALITY OF LIFE |
30 days |
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
Phase of Trial
|
Phase 2/ Phase 3 |
Date of First Enrollment (India)
|
15/05/2022 |
Date of Study Completion (India) |
19/12/2023 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
19/12/2023 |
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Vicharchika is a type of kshudra kushta. It is characterized by, kandu (itching sensation), Bahu Srava (excessive exudation), Shyava Varna (blackish brown discoloration) and Pidaka (Papule). It is similar to Dermatitis (eczema), which refers to a heterogeneous group of disorders that share similarities in clinical appearance and histopathologic findings, but may have different etiologies. Acute dermatitis often appears vesicular (like water boiling on the skin), whereas chronic dermatitis may be red, scaly, and lichenified. Pruritus is a common symptom of all types of dermatitis. Dermatitis was estimated to affect 245 million people globally in 2015, or 3.34% of the world population. About 10-20% of the general practice includes the patients suffering from skin disorders and Eczema accounts for a very large proportion of all the skin diseases. According to Acharya Charaka, vicharchika is characterized by skin manifestation having the lakshanas kandu, pidaka, shyava Varna and bahu srava. Acharya Charka mentioned the predominance of kapha dosha in vicharchika. This study is intended to evaluate the effectiveness of Navakashaya internally, indicated in kushta chikista and Vidangadi Lepa externally. Ingredients of Navakashya possess tikta rasa, laghu ruksha guna, ushna virya, katu vipaka, kushtagna properties which are opposite to the qualities of kapha. The external treatment Vidangadi lepa has properties like tikta rasa, laghu ruksha guna and kushtagna. The ingredients of both formulations are easily available. There are many shamana oushadies explained in the management of vicharchika, but there is still a need for an effective formulation. Hence this study aims at evaluating the combined effectiveness of Navakashaya internally 30 ml thrice daily, before food and Vidangadi Lepa externally once daily in day time for a period of 30 days in vicharchika. Subjects will be followed on 15 th and 30th days of treatment. |