| CTRI Number |
CTRI/2017/06/008823 [Registered on: 13/06/2017] Trial Registered Prospectively |
| Last Modified On: |
24/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
ROLE OF SHODHANA ON PROPERTIES OF KARAVIRA ROOT BARK AND MANAGEMENT OF ECZEMA BY RAKTA KARAVIRA TAILA. |
|
Scientific Title of Study
|
Impact of Shodhana on Phyto-pharmacological properties of different source plants of Karavira root bark and clinical efficacy of Rakta karavira taila on Vicharchika. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vivek Kumar Patel |
| Designation |
MD Second Year |
| Affiliation |
Institute of post graduate teaching and research in ayurveda |
| Address |
Room no 67 PG Boys Hostel Institute of post graduate teaching and research in Ayurveda Gujarat ayurved university jamnagar
OPD no 17 Institute of post graduate teaching and research in Ayurveda Gujarat ayurved university jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9714486694 |
| Fax |
|
| Email |
vivekkmr009@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Rabinarayan Acharya |
| Designation |
MD(Ayu) PhD |
| Affiliation |
Institute of post graduate teaching and research in Ayurveda |
| Address |
Room no 329 Institute of post graduate teaching and research in Ayurveda Gujarat ayurved university jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9924585855 |
| Fax |
|
| Email |
drrnacharya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vivek Kumar Patel |
| Designation |
MD Second Year |
| Affiliation |
Institute of post graduate teaching and research in ayurveda |
| Address |
ROOM NO 67 PG BOYS HOSTEL Institute of post graduate teaching and research in Ayurveda Gujarat Ayurved University Jamnagar
OPD no 17 PG BOYS HOSTEL Institute of post graduate teaching and research in Ayurveda Gujarat Ayurved University Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9714486694 |
| Fax |
|
| Email |
vivekkmr009@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jamnagar arid zone Gujarat ,India |
|
|
Primary Sponsor
|
| Name |
Institute of post graduate teaching and research in Ayurveda |
| Address |
Gujarat Ayurved University Jamnagar |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Vivek Kumar Patel |
Institute of post graduate teaching and research in Ayurveda |
OPD no.17 Institute of post graduate teaching and research in Ayurveda,Gujarat
Ayurved University,Jamnagar
Jamnagar
GUJARAT |
9714486694
vivekkmr009@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee jamnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
1. Classical signs and symptoms of Vicharchika i.e Kandu(Itching), Pidika(Furuncle),Vaivarna(Discoloration),Daha(Burning sensation),Rukshata(Roughness),Vedana(Pain)etc., (1) ICD-10 Condition: L909||Atrophic disorder of skin, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nerium indicum Mill. |
As per required for affected
area of patches,Local
application, morning & night, 28 days duration |
| Comparator Agent |
Nill |
Nill |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Classical signs and symptoms of Vicharchika lika Kandu,Pidika,Vaivarna,Daha,Rukhshata,vedana etc.
2.Uncomplicated case of Vicharchika.
3.Acute case of < 1 year history. |
|
| ExclusionCriteria |
| Details |
1.Suffering with systemic diseases like Diabetes,Hypertension,Malignancy,Tuberculosis,Renal diseases,Liver diseases etc.
2.Chronic case of > 1year history.
3.Lession of larger surface area. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Relief in Itching,Burning sensation,Roughness,Pain etc.
symptoms of Vicharchika. |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Kandu(Itching),Pidika(Furuncle),Vaivarnata(Discoloration),Daha(Burning sensation),Rukshata(Roughness),Vedana(Pain)etc. |
up to 28 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "28"
Final Enrollment numbers achieved (India)="28" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
03/07/2017 |
| Date of Study Completion (India) |
20/02/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Patel VK, Acharya RN. Management of
Vicharchika (Eczema) with Rakta Karavira Taila: An Open-label Clinical
Study. J Res Ayurvedic Sci 2020;4(2):65–71. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
An open labelled pilot clinical study was carried out to
assess the role of Rakta KaravÄ«ra Taila on patients of VicarcikÄ after getting
approval of IEC (Ref no: PGT/7/-A/ethics/2015-16/2796;Dated-25/11/2016). The study was registered in CTRI (CTRI/2017/06/008823;
Dated-13/06/17). Clinically diagnosed 30
cases of VicarcikÄ among the patients visiting the OPD of Dravyaguna department
were selected. Test drug was supplied to all the patients weekly for topical
application (as per surface area of lesion) for a duration of 4 week (28 days).
Weekly assessment was done by self-assessment
questionnaire and EASI (eczema area and severity index) score parameters.
Among 30 patients, 2 discontinued due to personal reasons
at very begining. In the registered 28 cases who completed the treatment.
Statistical analysis was done by applying Unpaired’t’-test for assessing the
difference of pre and post EASI score.
After
weekly assessment it was found that there was progressive improvement observed
in all the considering symptoms of VicarcikÄ like Kaṇdu, PidikÄ, VaivarnyatÄ,
DÄha, VedandÄ and Ruká¹£atÄ up to 3rd week of study period. After that
relief was steady in case of DÄha and VedanÄ, slow improvement in Kaṇdu,
VaivurnyatÄ and Ruká¹£atÄ. Decrease in relief in case of PidikÄ was observed on 4th
week.
Ovar all effect of Therapy: There was mild to
moderate improvement in the score after treatment as per Äyurvedic parameter as
well as EASI parameters. One patient didn’t show any improvement on the basis
of EASI parameters. Overall effect of Therapy on chief complaints like Kaṇdu
(Itching) 60.49% relief; Piá¸ikÄ (Pappilae) got 33.33% relief; VaivarṇyatÄ
(Discolouration) got 43.90% relief; DÄha (Burning sensation) got 50% relief;
VedanÄ (Pain) got 80% relief and Ruká¹£atÄ (Dryness) got 57.32% relief. Effect of
Therapy on EASI parameters like Redness got 42.86% relief; Thickness got 55.56%
relief; Scratching got 45.06% relief and Lichenification got 41.67% relief. No
adverse reactions were reported during trail.1. Rakta
Karavīra Taila, an anubhuta yoga is a fast acting drug against all the assessed
symptoms of VicarcikÄ like Kaṇá¸u, PidikÄ, VaivarnyatÄ, DÄha, VedandÄ and Ruká¹£atÄ.
However, rate of improvement was slow down between 3rd and 4th
week, but was still improving instead except in case of PidikÄ.
2. Rakta
Karavīra Taila has a mild to moderate improvement in reducing the symptoms of
VicarcikÄ within 28 days of administration.
|