| CTRI Number |
CTRI/2017/05/008722 [Registered on: 31/05/2017] Trial Registered Prospectively |
| Last Modified On: |
29/05/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Pre clinical and Clinical evaluation of karappan nei (internal and external medicine) in the treatment of Eczema in children |
|
Scientific Title of Study
|
Preclinical and Clinical evaluation of karappan nei (internal and external medicine) in the treatment of Bala karappan (Eczema) in children on open clinical study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bakkiyadevi M |
| Designation |
PG Scholar |
| Affiliation |
Ayothidoss pandithar hospital |
| Address |
Department of Kuzhandhai Maruthuvam, National institute of Siddha, Tambaram sanatorium, Chennai 47
Department of Kuzhandhai Maruthuvam, National institute of Siddha, Tambaram sanatorium, Chennai 47
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9994627411 |
| Fax |
|
| Email |
bakkiyadevim@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Suresh |
| Designation |
Lecturer |
| Affiliation |
Ayothidoss pandithar hospital |
| Address |
Department of Kuzhandhai Maruthuvam, National institute of Siddha, Tambaram sanatorium, Chennai 47
Department of Kuzhandhai Maruthuvam, National institute of Siddha, Tambaram sanatorium, Chennai 47
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9962571137 |
| Fax |
|
| Email |
drsureshherbal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr K Suresh |
| Designation |
Lecturer |
| Affiliation |
National institute of siddha |
| Address |
Department of Kuzhandhai Maruthuvam, National institute of Siddha, Tambaram sanatorium, Chennai 47
Department of Kuzhandhai Maruthuvam, National institute of Siddha, Tambaram sanatorium, Chennai 47
TAMIL NADU
600047
India |
| Phone |
9962571137 |
| Fax |
|
| Email |
drsureshherbal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayothidoss pandithar hospital National institute of siddha,Tambaram sanatorium, Chennai-47. |
|
|
Primary Sponsor
|
| Name |
Ayothidoss pandithar hospital |
| Address |
National Institute of siddha,Tambaram sanatorium, Cheenai-47 |
| 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 Bakkiyadevi M |
Ayothidoss pandithar hospital |
OPD NO 9, Department of Kuzhanthai maruthuvam, National Institute of Siddha, Tambaram Sanatorium
Kancheepuram
TAMIL NADU |
9994627411
bakkiyadevim@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 |
Bala karappan, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Karappan nei(internal) |
5-10 ml twice a day with honey for a period of 48 days |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Children with symptoms of pain in lower extremities, Itching, Papules, Vesicles, Pustules, Ulcer, Oozing, Hyper pigmentation, Sleep disturbances
2.Patients willing to Blood investigation when required
3. Patient willing to be admitted in the hospital or willing to attend OPD once in 7 days for 48 days. |
|
| ExclusionCriteria |
| Details |
1.Scabies
2. Photo dermatitis
3. Jaundice
4. patients with any other serious illness |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It is mainly assessed by reduction of Clinical symptoms by using SCORAD scale |
48 datys |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| It is mainly assessed by therapeutic efficacy of the trial drugs |
48 days |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/08/2017 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
It is the single non-randomized,open label trial to determine the efficacy of Karppan nei (internal and external medicine) prepared from herbal constitutents in the patients with Balakarappan (Eczema). In this trial 30 patients will be recruited and the trial drug will be administered 5-10 ml Twice a day with honey for a period of 48 days. During the trial period if any AE/SAE/SUSAR will be noticed and refered to pharmacovigilance department in NIS and further management will also be given in NIS OPD/IPD. The entire trial will be monitored by the research monitoring committee of NIS. During this trial all the safety efficacy parameters will be recorded in the CRF. After completion of the trial all the study related data will be analysed statistically. The outcome of this trial will be published in India Journal of Medical research. |