CTRI Number |
CTRI/2019/05/019214 [Registered on: 20/05/2019] Trial Registered Prospectively |
Last Modified On: |
16/05/2019 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Siddha |
Study Design |
Single Arm Study |
Public Title of Study
|
A clinical study on Karisalai mathirai for Pitha paandu (Iron deficiency Anaemia) |
Scientific Title of Study
|
A prospective open labelled , Non-randomized ,phase II clinical trial of Karisalai mathirai in the management of Pitha paandu (Iron deficiency Anaemia) |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
A Karthick |
Designation |
PG scholar |
Affiliation |
Govt Siddha Medical college |
Address |
II year PG Scholar Department of Pothu Maruthuvam
Govt Siddha Medical college Palayamkottai Tirunelveli
Tirunelveli TAMIL NADU 627002 India |
Phone |
9042516331 |
Fax |
|
Email |
draskarthick@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr A Manoharan MD Ph D |
Designation |
Professor and HOD |
Affiliation |
Govt Siddha Medical college and hospital Palayamkottai Tirunelveli |
Address |
Department of Pothu Maruthuvam
Govt Siddha Medical college and hospital Palayamkottai
Tirunelveli TAMIL NADU 627002 India |
Phone |
9443886700 |
Fax |
|
Email |
drmanoharan25@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr G SubashChandran MD PhD |
Designation |
Lecturer grade II |
Affiliation |
Govt Siddha Medical college and hospital Palayamkottai Tirunelveli |
Address |
Department of Pothu Maruthuvam
Govt Siddha Medical college and hospital Palayamkottai
Tirunelveli TAMIL NADU 627002 India |
Phone |
9443358271 |
Fax |
|
Email |
siddhadrgs21@gmail.com |
|
Source of Monetary or Material Support
|
IPD and OPD facilities and central library of Govt Siddha Medical College and Hospital, Palayamkottai |
|
Primary Sponsor
|
Name |
Govt Siddha Medical College and Hospital |
Address |
Palayamkottai,
Tirunelveli
Tamil nadu
627002
|
Type of Sponsor |
Government medical college |
|
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 KARTHICK |
Govt Siddha Medical College and Hospital |
OP no 10 PG
Department of Pothu Maruthuvam
Govt Siddha Medical College and Hospital
Palayamkottai, Tirunelveli 627002 Tirunelveli TAMIL NADU |
9042516331
draskarthick@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethical Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: D509||Iron deficiency anemia, unspecified, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
KARISALAI MATHIRAI |
1-2 Tablet BD A/F along With Butter Milk for 45 days |
Comparator Agent |
NIL |
NIL |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1.Hb level between 7.1 - 10 grams
2. Pallor of skin , mucous membrane, conjuctiva, nailbeds
3. Fatigue, shortness of breath, palpitation
4. Anorexia
5.Blood loss due to menstrual disorders,hemorrhoids and peptic ulcer |
|
ExclusionCriteria |
Details |
1. Congenital heart disease
2. Patients with chronic renal disease
3. Liver disease
4.Inherited hemolytic defects
5.Thalassemia
6. Thyroid disease
7.Diabetes mellitus
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
1. Relief of clinical symptoms mentioned in inclusion criteria
2. Increase in HB level
3. Improvement in lab parameters |
45 days |
|
Secondary Outcome
|
Outcome |
TimePoints |
1. Evaluation of heamatinic activity of trial drug
2. Evaluation of additional effects and changes of siddha parameters in Pitha Paandu
3.Evaluation of safety profile, Biochemical and pharmacological parameters of trial drug. |
45 days |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
21/05/2019 |
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
|
none yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
The study is a prospective open labelled ,non- randomized , phase II clinical study to evaluate the therapeutic efficacy of KARISALAI MATHIRAI in the management of Pitha Paandu(iron deficiency aneamia). The trial drug will be administered at the dose of 1-2 tablets BD A/F along with Butter milk for 45 days in 60 patients . The trial period of 12 months will be carrying out in Govt Siddha Medical College and Hospital, Palayamkottai , Tirunelveli ,Tamilnadu. The primary outcome will be the evaluation of therapeutic efficacy of trial drug KARISALAI MATHIRAI. The secondary outcome will be evaluation of Siddha diagnostic parameters , assessment of safety profile, pharmacological and biochemical parameters of trial drug. |