| CTRI Number |
CTRI/2018/04/013122 [Registered on: 09/04/2018] Trial Registered Prospectively |
| Last Modified On: |
06/04/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to study the effect of Siddha drug Thiripalai mathirai in Pitha Paandu (Iron deficiency anaemia) |
|
Scientific Title of Study
|
A prospective open labelled non-randomized phaseII clinical trial to evaluate the therapeutic efficacy of the Siddha medicine "Thiripalai Mathirai" (Internal) for the treatment 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 |
Maheshwari B |
| Designation |
PG student |
| Affiliation |
Govt Siddha Medical College and Hospital Palayamkottai |
| Address |
PG Second year
Department of Pothu Maruthuvam
Govt Siddha Medical College and Hospital
Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
7639854840 |
| Fax |
|
| Email |
maggi.b1992@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr T Komalavalli MD Siddha PhD |
| Designation |
Associate Professor |
| Affiliation |
Govt Siddha Medical College and Hospital Palayamkottai |
| Address |
Associate Professor
Department of Pothu Maruthuvam
Govt Siddha Medical College and Hospital
Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9788122691 |
| Fax |
|
| Email |
komalaarumugam1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr T Komalavalli MD Siddha PhD |
| Designation |
Associate Professor |
| Affiliation |
Govt Siddha Medical College and Hospital Palayamkottai |
| Address |
Associate Professor
Department of Pothu Maruthuvam
Govt Siddha Medical College and Hospital
Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9788122691 |
| Fax |
|
| Email |
komalaarumugam1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Library
Government Siddha Medical College and Hospital
Palayamkottai
Tirunelveli |
| OPD and IPD
Government Siddha Medical College and Hospital
Palayamkottai
Tirunelveli |
|
|
Primary Sponsor
|
| Name |
Dr S Neelavathi MD Siddha PhD |
| Address |
Principal
Government Siddha Medical College and Hospital
Palayamkottai
Tirunelveli |
| 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 |
| Maheshwari B |
Govt Siddha Medical College and Hospital Palayamkottai |
OPD and IPD
PG Department of Pothu Maruthuvam
Govt Siddha Medical College and Hospital
Palayamkottai
Tirunelveli
TAMIL NADU |
7639854840
maggi.b1992@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 |
Pitha Paandu
Iron Deficiency Anaemia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Thiripalai Mathirai with adjuvant Karisalai Kudineer |
Thiripalai Mathirai 1 tablet with 100ml of Karisalai kudineer BD for 30 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Hb level between 7 to 10 grams
Pallor of skin mucous membrane conjunctiva nailbeds
Fatigue Shortness of breath Palpitation Anorexia
Worm infestations
Blood loss due to Menstrual disorders Hemorrhoids Peptic ulcer
Smear showing hypochromic microcytic RBCs |
|
| ExclusionCriteria |
| Details |
Patients with Congenital heart disease Chronic renal disease Liver disease Inherited haemolytic defects Thalessemia Thyroid disorder Diabetes mellitus |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical and Therapeutic efficacy of the siddha medicine Thiripalai Mathirai in Pitha Paandu |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Evaluation of siddha diagnostic parameters
Safety of trial drug and the adjuvant
Pharmacological and biochemical analysis of trial drug and the adjuvant
|
30 days |
|
|
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)
|
16/04/2018 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not 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 2 Clinical trial to evaluate the therapeutic efficacy of THIRIPALAI MATHIRAI 1 with the adjuvant KARISALAI KUDINEER 100ml BD for 30 days in 40 patients during the trial period of 20 months that will be conducted in Govt Siddha Medical College and Hospital Palayamkottai Tirunelveli Tamilnadu India The primary outcome will be the therapeutic efficacy of trial medicine Thiripalai Mathirai with the adjuvant Karisalai kudineer The secondary outcome will be the evaluation of siddha diagnostic parameters Safety of trial drug and the adjuvant Pharmacological and Biochemical analysis of trial drug and the adjuvant |