| CTRI Number |
CTRI/2020/08/027269 [Registered on: 20/08/2020] Trial Registered Prospectively |
| Last Modified On: |
19/08/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Arka Taila and Its Cream In Vicharchika |
|
Scientific Title of Study
|
Pharmaceutico Analytical and Clinical Evaluation of Arka Taila and Its Cream In The Management of Vicharchika |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhupender Kumar |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
PG Deparment of Rasashastra and Bhaishajya Kalpana National Institute of Ayurveda
Jaipur
RAJASTHAN
302002
India |
| Phone |
9050084284 |
| Fax |
|
| Email |
drbpsharma.com@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof K Shankar Rao |
| Designation |
HOD and Professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
PG Deparment of Rasashastra and Bhaishajya Kalpana National Institute of Ayurveda
Jaipur
RAJASTHAN
302002
India |
| Phone |
9887181781 |
| Fax |
|
| Email |
headrasa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhupender Kumar |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
PG Deparment of Rasashastra and Bhaishajya Kalpana National Institute of Ayurveda
Jaipur
RAJASTHAN
302002
India |
| Phone |
9050084284 |
| Fax |
|
| Email |
drbpsharma.com@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute Of Ayurveda Jorawar Singh Gate Amer Road Jaipur 302002 |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
jorawarsingh Gate Amer Road Jaipur Rajasthan |
| 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 |
| Dr Bhupender Kumar |
National Institute of Ayurveda Hospital Jaipur |
OPD No 6, PG Dept. of Rasashastra and Bhaishajya Kalpana, Madhav Vilas Palace Amer Road Jaipur, 302002 Jaipur RAJASTHAN
Jaipur
RAJASTHAN |
9050084284
drbpsharma.com@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE OF NATIONAL INSTITUTE OF AYURVEDA JAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L209||Atopic dermatitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Arka cream and Aarogyavardhini vati |
Arka cream for external application as per the requirement two times a day along
with internal administration of Aarogyavardhini vati 250 mg TDS |
| Intervention |
Arka taila and Arogyavardhini Vati |
Arka taila for external application as per the requirement two times a day along with
internal administration of Arogyavardhini Vati 250mg TDS |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having clinical signs and symptoms of Vicharchika like Kandu, srava, shyava varna.
2.Patients between the age group of (18-70) years of age.
3.Patients of Dry Eczema |
|
| ExclusionCriteria |
| Details |
1.Patients suffering from chronic skin diseases.
2.Patients of Vicharchika having secondary infection
3.Patients under long term Steroids and cytotoxic treatments.
4.Patients with concomitant illness like HTN, DM.
5.Patients with evidence of malignancy. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare Clinical efficacy of arka tail and its cream in vicharchika |
28 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
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 1 |
|
Date of First Enrollment (India)
|
24/08/2020 |
| 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="0"
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)?
Response - NO
|
|
Brief Summary
|
Vicharchika is one amongst eleven varieties of Kshudra kushta. The disease is characterized by shyava varna and kanduyukta pidikas over the extremities. The disease poses lot of discomfort and trouble to the sufferer. The patients are running pillar to post for relief from this miserable condition. This condition is correlated to Eczema of the Modern medical science. Eczema or dermatitis is an inflammatory response of the skin to multiple external stimuli. It is one among the chronic skin ailment, affecting, and the population irrespective of sex, age and socioeconomic status. Epidemiological studies reveal that Eczema affects 10 to 20% of total world population. Arka taila mentioned in Sarangdhara Samhita was found as a good choice. Arka taila contains ingredients like Arka Patra, Haridra and Sarsap Taila and is indicated in various skin disorders including Vicharchika. Considering a better patient acceptability of modified dosage forms it was decided to convert Arka taila in to cream form. Because they are non-sticky, requires low energy during formulation, are stable and have aesthetic value. AIMS & OBJECTIVE:- The present study will be carried out with the following aims & objectives. 1. To prepare Arka taila according to classical texts under proper SOP and SMP conditions. 2. To prepare Arka taila cream as per the standards of modern cosmetics. 3. To fix standards for the preparation, Analytical studies will be carried out. 4. To compare clinical efficacy of Arka taila and its cream in Vicharchika. Hypothesis : NULL Hypothesis :- There is no difference between efficacy of Arka taila and Arka cream. Alternate Hypothesis (H1) :- Arka taila is effective than Arka cream. Alternate Hypothesis (H2):- Arka cream is effective than Arka taila. |