CTRI Number |
CTRI/2017/05/008584 [Registered on: 17/05/2017] Trial Registered Prospectively |
Last Modified On: |
16/05/2017 |
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 study of Kukkil chooranam(Internal) and Thuvara ennai(External) in the treatment of Varicose ulcer(Nalavibatha viranam) |
Scientific Title of Study
|
Preclinical and clinical study of siddha drug "kukkil chooranam"(Internal medicine) and "thuvara ennai"(External medicine) in the treatment of pun (Naalavibatha pun- varicose ulcer) |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Mrs V Mahalakshmi |
Designation |
Lecturer |
Affiliation |
National Institute of Siddha |
Address |
Department of Sirappu Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai-600047
Kancheepuram TAMIL NADU 600047 India |
Phone |
9444519975 |
Fax |
|
Email |
rvmahalakshmi85@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Mrs V Mahalakshmi |
Designation |
Lecturer |
Affiliation |
National Institute of Siddha |
Address |
Department of Sirappu Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai-600047
TAMIL NADU 600047 India |
Phone |
9444519975 |
Fax |
|
Email |
rvmahalakshmi85@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Mrs V Mahalakshmi |
Designation |
Lecturer |
Affiliation |
National Institute of Siddha |
Address |
Department of Sirappu Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai-600047
TAMIL NADU 600047 India |
Phone |
9444519975 |
Fax |
|
Email |
rvmahalakshmi85@gmail.com |
|
Source of Monetary or Material Support
|
Ayothidass pandithar hospital, National institute of siddha |
|
Primary Sponsor
|
Name |
NATIONAL INSTITUTE OF SIDDHA |
Address |
NATIONAL INSTITUTE OF SIDDHA, TAMBARAM SANATORIUM, CHENNAI-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 C Sasikala |
Ayothidass pandithar hospital |
OPD no 3 and IPD, Department of sirappu maruthuvam,
National Institute of Siddha,
Tambaram Sanatorium, Chennai 600047. Kancheepuram TAMIL NADU |
7200600640 - sasiikala91@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics committee National Institute of Siddha |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Having varicose ulcers in legs, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
External Medicine - Thuvara Ennai |
Thuvara ennai is Oil based external Medicine - Quantity sufficient (approximately 25 Milli liter) for external application on the ulcers once a day for totally 48 days |
Intervention |
Internal Medicine - Kukkil Chooranam |
Kukkil Chooranam as a internal medicine by Oral route, - 01 grams, twice a day with honey and after meals for totally 48 days |
Comparator Agent |
NIL |
NIL |
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1.Presence of ulcers with varicose veins
With or without Pain, Itching, Edema, Fibrinous exudates in the lesions
2.Hyper pigmentation
3.Eczema around the ulcer
4.Inflammation
5.Induration
|
|
ExclusionCriteria |
Details |
1.Diabetes Mellitus
2.Hansen’s disease
3.Diabetic ulcer
4.Gangrene
5.Tuberculous ulcer
6.Any other systemic illness
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Case Record Numbers |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Reduction of varicose ulcer is assessed by Venous clinical severity score (VCSS) and reduction of associated symptoms of Varicose ulcer |
every 7 days for 3 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
Reduction of associated symptoms of Varicose ulcer |
03 months |
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
25/05/2017 |
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="3" 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 a single non randomized, open label trial to determine the efficacy of kukkil chooranam(Internal) prepared by herbal and mineral constituents and thuvara ennai(External) in patients with nalavibatha pun9Varicose ulcer). In this trial 40 patients will be recruited and the trial drug will be administered 1gm 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 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 jurnal of Medical research. |