| CTRI Number |
CTRI/2019/06/019921 [Registered on: 27/06/2019] Trial Registered Prospectively |
| Last Modified On: |
21/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical evaluation of the effect of a classical siddha drug akkara ennai for the treatment of Oral Ulcer |
|
Scientific Title of Study
|
Clinical Evaluation of the effect of AKKARA ENNAI in the management of ULLAKKARAM |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
A Arumuga Kani |
| Designation |
Post Graduate Student |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
Department of kuzhandhai maruthuvm
Government siddha medical college and hospital
Palayamkottai
Tirunelveli
Tirunelveli.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9500458608 |
| Fax |
|
| Email |
drkaniabinesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
D K Soundararajan |
| Designation |
Professor and Head |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
Department of kuzhandhai maruthuvm
Government siddha medical college and hospital
Palayamkottai
Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9442048801 |
| Fax |
|
| Email |
dr.dks.2012@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
D K Soundararajan |
| Designation |
Professor and Head |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
Department of kuzhandhai maruthuvm
Government siddha medical college and hospital
Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9442048801 |
| Fax |
|
| Email |
dr.dks.2012@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government siddha medical college and hospital
Palayamkottai
|
|
|
Primary Sponsor
|
| Name |
A Arumuga kani |
| Address |
Department of kuzhandhai maruthuvm
Government siddha medical college and hospital
Palayamkottai
Tirunelveli-627002
Tamil Nadu |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| A Arumuga Kani |
Government siddha medical college and hospital, |
OP No: 07, Department of Kuzhanthai Maruthuvam
Tirunelveli
TAMIL NADU |
9500458608
drkaniabinesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Istitutional Ethical Committee Government siddha medical college and hospital palayamkottai, Tirunelveli-627002, Tamil Nadu,India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K13||Other diseases of lip and oral mucosa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
akkara eṇṇey |
should be administered twice a day after food for a period of 5-7 days. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
subjects with any of followimg symptoms will be included in the study
1. ulceration in oral cavity
2. Coated tongue
3. Running nose
4. Fever
5. Excessive thirst
6. Pallor
|
|
| ExclusionCriteria |
| Details |
The diseases which required immediate medical attension such as
1. Oral cancer
2. Oral Candidiasis
3. Oral thrush due to HIV
will not be included from the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Pain.
2.Fever.
3.Coated Tongue. |
1-2 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Ulcer size reduction 2.Excessive Thirst
3.Running Nose
|
5-7 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "55"
Final Enrollment numbers achieved (India)="55" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
28/06/2019 |
| Date of Study Completion (India) |
24/03/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The Present study is single arm clinical trial to access the efficacy of akkara eṇṇey for the treatment of uḷ akkaram In this trial 40 patients will be recruited and the trial drug will be administered 7.5 ml twice a day for the period of 5-7 days. Primary outcome will be accessed by pain.Secondary outcome are reduction in size of ulcer and duration of ulcer. |