| CTRI Number |
CTRI/2022/02/040037 [Registered on: 04/02/2022] Trial Registered Prospectively |
| Last Modified On: |
03/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial on MUSUMUSKKAI KUDINEER in the management of PITHA PAANDU (IRON DEFICIENCY ANAEMIA) |
|
Scientific Title of Study
|
A Prospective Open labelled non randomized phase II clinical trial on MUSUMUSKKAI KUDINEER 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 |
DrPJeevitha |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
Second year PG Scholar, PG Department of Podhu Maruthuvam,OP no 10, Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli-627002
INDIA
Second year PG scholar, PG Department of Podhu Maruthuvam, OP no 10, Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli-627002
TAMIL NADU
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9629339197 |
| Fax |
|
| Email |
jeevithapalanisamy1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrGSubashchandran MDs PhD |
| Designation |
Lecturer |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
PG Department of Podhu Maruthuvam,OP no 10, Government Siddha Medical College and Hospital, Palayamkottai,Tirunelveli-627002
TAMIL NADU
PG Department of Podhu Maruthuvam, OP no 10, Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli-627002
TAMIL NADU
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443358271 |
| Fax |
|
| Email |
siddhadrgs21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr A Manoharan MDs PhD |
| Designation |
Professor |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
PG Department of Podhu Maruthuvam, OP no 10, Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli-627002
TAMIL NADU
PG Department of Podhu Maruthuvam, OP no 10, Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli-627002
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443886700 |
| Fax |
|
| Email |
drmanoharan25@gmail.com |
|
|
Source of Monetary or Material Support
|
| ›OPD and IPD facilities and Central Library of Government Siddha Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College and Hospital |
| Address |
Government Siddha Medical College and Hospital,Palayamkottai, Tirunelveli,Tamilnadu |
| 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 |
| P Jeevitha |
Government Siddha Medical College and Hospital |
PG Department of Podhu Maruthuvam, OP no 10,Government Siddha Medical College and Hospital,Palayamkottai, Tirunelveli-627002
Tirunelveli
TAMIL NADU |
9629339197
jeevithapalanisamy1997@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 |
MUSUMUSKKAI KUDINEER |
30-60 ml Twice a day (orally) |
| Comparator Agent |
NIL |
0 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
1.Hb level above 7.0 grams - below 10 grams
2.Patient with the symptoms of Pallor of skin, Mucous membrane, Conjunctiva, Nail beds. Fatigue, shortness of breath, palpitation. Worm infestations. Blood loss due to Menstrual disorders, Hemorrhoids, and Peptic ulcer
3.Clinically diagnosis in Iron Deficiency Anaemia, smear showing hypochromic microcytic anaemia |
|
| ExclusionCriteria |
| Details |
1.Hb levels below 7.0 grams and above 10 grams
2.Congenital heart diseases
3.Patients with chronic renal diseases
4.Liver diseases
5.Inherited hemolytic defects
6.Thalassemia
7.Thyroid disorder
8.Diabetes mellitus
9.Pregnancy and lactating mother |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the therapeutic efficacy of clinical trial drug in management of Pitha Paandu |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To evaluate the biochemical physico-chemical and phytochemical analysis of clinical trial drug
2.To evaluate the antimicrobial activity of trial drug
3.To evaluate the safety profile for acute and subacute toxicity of the trial drug musumuskkai kudineer
4.To evaluate pharmacological analysis of the clinical trial drug
5.To evaluate Siddha parameters and modern parameters during the treatment of Pitha Paandu with trial drug
6.To evaluate the statistical analysis of the clinical trial drug musumuskkai kudineer |
45 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)
|
12/02/2022 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is a Prospective Open Labelled phase II non randomized clinical study to evaluate the therapeutic efficacy of MUSUMUSKKAI KUDINEER in the management of PITHA PAANDU (IRON DEFICIENCY ANAEMIA) .The trial drug will be administrated at the dose of 30-60 ml twice a day (orally) A/F 45 days in 40 patients. The trial period of 12 months will be carried out in Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli, Tamilnadu. The primary outcome will be evaluation of therapeutic efficacy of trial drug MUSUMUSKKAI KUDINEER. The secondary outcome will be the evaluations of siddha diagnostic parameters, assessment of safety profile of trial drug, assessment of pharmacological and biochemical parameters of trial drug. In case of any adverse events (AE) is noticed and it will be referred to pharmacovigilance department of SCRI. Further management of patients will be given in OPD facility. |