| CTRI Number |
CTRI/2020/03/023942 [Registered on: 13/03/2020] Trial Registered Prospectively |
| Last Modified On: |
27/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effects of two drugs,
Eugenia jambolana and Syzygium caryophyllatum leaf in patients with Acne vulgaris |
|
Scientific Title of Study
|
Comparative phyto-pharmocognostic and clinical evaluation of Jambu(Eugenia jambolana Lam.) And Kshudra Jambu(Syzygium caryophyllatum (L.) Alston) W.S.R to their efficacy in youvana pidaka. |
| Trial Acronym |
EJSC |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Suma H R |
| Designation |
PG scholar, department of dravyaguna |
| Affiliation |
SDM College of ayurveda and hospital |
| Address |
Dr Suma H R,2nd year Pg scholar, department of pg studies in dravyaguna, SDM College of ayurveda,kuthpady,udupi
Kuthpady,udupi
Udupi
KARNATAKA
574118
India |
| Phone |
9449304574 |
| Fax |
|
| Email |
vaidyasuma@outlook.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suma H R |
| Designation |
PG scholar, department of dravyaguna |
| Affiliation |
SDM College of ayurveda and hospital |
| Address |
Dr Suma H R,2nd year Pg scholar, department of pg studies in dravyaguna, SDM College of ayurveda,kuthpady,udupi
Kuthpady,udupi
Udupi
KARNATAKA
574118
India |
| Phone |
9449304574 |
| Fax |
|
| Email |
vaidyasuma@outlook.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suma H R |
| Designation |
PG scholar, department of dravyaguna |
| Affiliation |
SDM College of ayurveda and hospital |
| Address |
Dr Suma H R,2nd year Pg scholar, department of pg studies in dravyaguna, SDM College of ayurveda,kuthpady,udupi
Kuthpady,udupi
Udupi
KARNATAKA
574118
India |
| Phone |
9449304574 |
| Fax |
|
| Email |
vaidyasuma@outlook.com |
|
|
Source of Monetary or Material Support
|
| Ravindra H L, central government employee, NIC, father of Dr Suma h r, door number 3, Surabhi, 8th cross, Ganesh Nagar layout, kodigehalli, Bangalore-560097,mobile-9449037427 |
|
|
Primary Sponsor
|
| Name |
Ravindra H L |
| Address |
Door number 3,Surabhi,8th cross,Ganesh nagar layout,kodigehalli, Bangalore-560097,mobile-9449037427 |
| Type of Sponsor |
Other [Father] |
|
|
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 Shrikanth P |
SDM College of ayurveda |
SDM colly of ayurveda and hospital,kuthpady,udupi
Udupi
KARNATAKA |
9449329823
drshrikanth.acharya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L088||Other specified local infections of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Oral administration and external application of mature leaf powder of Kshudra jambu |
Oral administration-6gm twice a day with hot water,after food.
External application- Kshudra jambu leaft powder to face with water and removal after drying with water |
| Comparator Agent |
Oral administration and external application of powder of mature leaf of Jambu. |
Oral administration-6gm twice a day with warm water after food.
External application- Jambu leaf churna to face with water and removal after drying with water |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Shalmali kantaka pidaka, Sarika pidaka, Ghana pidaka, medogarbha |
|
| ExclusionCriteria |
| Details |
Any systemic illness that requires treatment which might interfere with present clinical trial. Diabetis mellitus, hypertension,Acne rosaceae, Syncosis barbar, gram negative folliculitis |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Disease management |
Disease management |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Minimum side effects and less reoccurence of signs and symptoms |
30 days after the stopage of intervention |
|
|
Target Sample Size
|
Total Sample Size="133920"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
18/03/2020 |
| 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)?
|
|
Brief Summary
|
Jambu and Kshudra jambu are used by folklore practicioners of western ghats for the treatment of Acne vulgaris. Jambu has property similar to that of kshudra jambu and is said to be twak prasadaka and vrana ropaka. Acne is a common skin condition having prevalence rate of 76.2%. An attempt is made to find a cost-effective drug for the treatment of Acne vulgaris and also to compare the two Jambu varieties clinically. |