| CTRI Number |
CTRI/2018/02/012071 [Registered on: 22/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
20/02/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial on vitiligo |
|
Scientific Title of Study
|
Comparative study on clinical evaluation of Mayiliragaadhi chooranam (internal ) and Kandangkathiri ennai (external)versus kandangkathiri Ennai (external)only-a siddha drug for Venpadai(vitiligo)- as Pilot study. |
| Trial Acronym |
vitiligo |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PAlarmelmangai |
| Designation |
pg scholar |
| Affiliation |
National Institute of Siddha |
| Address |
National Institute of Siddha
Department of kuzhandhai maruthuvam
Tambaram sanatorium
Chennai
National Institute of Siddha
Department of kuzhandhai maruthuvam
Tambaram sanatorium
chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
9677146683 |
| Fax |
|
| Email |
eq.alarmelmangai@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MMeenakshi sundaram |
| Designation |
Head of the department |
| Affiliation |
National Institute of Siddha |
| Address |
National Institute of Siddha
Department of kuzhandhai maruthuvam
Tambaram sanatorium
chennai
National Institute of Siddha
Department of kuzhandhai maruthuvam
Tambaram sanatorium
chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
9444214582 |
| Fax |
|
| Email |
mmssiddha@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MMeenakshi sundaram |
| Designation |
Head of the department |
| Affiliation |
National Institute of Siddha |
| Address |
National Institute of Siddha
Department of kuzhandhai maruthuvam
Tambaram sanatorium
chennai
National Institute of Siddha
Department of kuzhandhai maruthuvam
Tambaram sanatorium
chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
9444214582 |
| Fax |
|
| Email |
mmssiddha@rediffmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
National institute of siddha |
| Address |
National institute of siddha
Ayothidass hospital
tambaram sanatorium |
| 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 |
| PAlarmelmangai |
National Institute of Siddha |
National Institute of Siddha
Department of kuzhandhai maruthuvam
Tambaram sanatorium
chennai
Chennai
TAMIL NADU |
9677146683
eq.alarmelmangai@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
hypopigmented patches on the body, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
mayiliragadhi chooranam (internal medicine)
kandangathiri ennai (external medicine) |
oral administration 1gm b.i.d for 48 days |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Age: Between 5 to 12 years
Sex: Both male and female children
Hypo pigmented patches with hyper pigmented border without any structural changes in any part of the body
Willing to co operate for taking photographs whenever required with hisher consent
|
|
| ExclusionCriteria |
| Details |
1.Albinism
2.Thyroid disorder
3.Leprosy
4.HIV
5.Fungal infestation
6.Burns
Patient with lesion in the lips ,sole , palm and genitalia
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction of the hypopigmented lesions in the affected area |
45 days after medications |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in the recurrence rate of the lesions. |
after 48 days |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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 2 |
|
Date of First Enrollment (India)
|
27/09/2016 |
| 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="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
After completion of the clinical trial |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
It is an Open clinical trial, to evaluate the therapeutic efficacy of Mayiliragadhi chooranam internal medicine and kandangathiri ennai external medicine from the siddha texts gunapadam thaadhu and mooligai vaguppu. The
ingridients are thippili ,seeragam,mayiliragu 1gm b.i.d orally with honey for 48 days and kandankathiri pazha chaaru with olive oil external medicine. The treatment will be given for 48 days. The Laboratory investigations
and Clinical assessments will be recorded periodically before and after
treatment period. All the trial related data will be recordered in Case Report
Form (CRF) for each patient separately. At the end of trial all the data will be
analysed statistically and the research reports will be Published |