| CTRI Number |
CTRI/2019/10/021642 [Registered on: 14/10/2019] Trial Registered Prospectively |
| Last Modified On: |
10/10/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Randomized controlled study on Brihat HaridraKhanda And Haridrakhanda in the management of Chronic Urticaria (Sheet Pitta,Udarda,Kotha) |
|
Scientific Title of Study
|
A RANDOMIZED CONTROLLED STUDY ON BRIHAT HARIDRAKHANDA IN THE MANAGEMENT OF CHRONIC URTICARIA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Naishadh Bharatkumar Sharma |
| Designation |
PG Scholar, Parul Institute of Ayurved |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Kayachikitsa Department,
Parul Institute of Ayurved,
Parul University,P.O Limda,
Waghodia, District Vadodara,
Gujarat-391760
Vadodara
GUJARAT
391760
India |
| Phone |
7874016363 |
| Fax |
|
| Email |
drnaishadhbharatsharma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Prakash Kumbar |
| Designation |
Reader in Parul Institute of Ayurved |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Kayachikitsa Department,
Parul Institute of Ayurved,
Parul University,P.O Limda,
Waghodia, District Vadodara,
Gujarat-391760
Vadodara
GUJARAT
391760
India |
| Phone |
9916204070 |
| Fax |
|
| Email |
drprakash.kc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Prakash Kumbar |
| Designation |
Reader in Parul Institute of Ayurved |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Kayachikitsa Department,
Parul Institute of Ayurved,
Parul University,P.O Limda,
Waghodia, District Vadodara,
Gujarat-391760
Vadodara
GUJARAT
391760
India |
| Phone |
9916204070 |
| Fax |
|
| Email |
drprakash.kc@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Parul Institute of Ayurved |
| Address |
Parul Institute Of Ayurved
P.O Limda, Waghodia,
District Vadodara
Gujarat. |
| 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 Naishadh Bharatkumar Sharma |
Parul Institute of Ayurved and Hospital |
OPD NO-106
Kayachikitsa Department
Parul Ayurved Hospital,
Parul University,
Post – Limda, Tal – Waghodia, VADODARA-391760
Vadodara
GUJARAT |
7874016363
drnaishadhbharatsharma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L509||Urticaria, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group-A Brihat Haridrakhand |
Orally 4 Gram Thrice in a day after meal with Usnodak for 30Days. |
| Intervention |
Group-B Haridrakhand |
Orally 4 Gram Thrice in a day after meal with Usnodak for 30Days. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed case of Chronic Urticaria patients will be selected. |
|
| ExclusionCriteria |
| Details |
Major systemic illness like CRF, DM, Thyroid related disease.
History of Anaphylaxis to medicine and food.
Patients suffering from other skin diseases such as eczema, Psoriasis or other skin disease. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| All the signs and symptoms of chronic urticaria will be assigned score depending upon their severity to assess the effect of the drugs at the time of Before and After treatment. |
30 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
14/10/2019 |
| 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
|
Not Published yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This Study is a Randomized, Parallel Group, Active Controlled trial to compare the efficacy of Brihat Haridrakhand in the Dose of 4 Gram TID with the vehicle of Ushnodak for the duration of 30 Days in 15 Patients of Chronic Urticaria and Haridrakhand in the Dose of 4 Gram TID with the vehicle of Ushnodak for the duration of 30 Days in 15 Patients of Chronic Urticaria will be conducted in India. |