| CTRI Number |
CTRI/2018/01/011179 [Registered on: 08/01/2018] Trial Registered Prospectively |
| Last Modified On: |
07/01/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical study of siddha medicine "Chitramutti Nei" in the treatment of Azhal Pandu(Iron deficiency anemia) |
|
Scientific Title of Study
|
A clinical evaluation of siddha drug "Chitramutti Nei" (Internal) in the treatment of Azhal Pandu (Iron deficiency anemia) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrMSShakila |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
National institute of Siddha
Department of Maruthuvam
Tambaram Sanatorium
Kanchipuram
Department of Maruthuvam
Tambaram Sanatorium
Kanchipuram
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
8681918617 |
| Fax |
04422381314 |
| Email |
shakilav2010@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrKManickavasagam |
| Designation |
Head of the department |
| Affiliation |
National institute of Siddha |
| Address |
National institute of Siddha
Department of Maruthuvam
Tambaram Sanatorium
Kanchipuram
Department of Maruthuvam
Tambaram Sanatorium
Kanchipuram
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9444249798 |
| Fax |
04422381314 |
| Email |
dr.kmvm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrHVetha Merlin kumari |
| Designation |
Lecturer |
| Affiliation |
National institute of Siddha |
| Address |
National institute of Siddha
Department of Maruthuvam
Tambaram Sanatorium
Kanchipuram
Department of Maruthuvam
Tambaram Sanatorium
Kanchipuram
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9894782366 |
| Fax |
04422381314 |
| Email |
dr.vetha@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Siddha
Tambaram sanatorium
Chennai 47 |
|
|
Primary Sponsor
|
| Name |
Ayothidoss Pandithar Hospital |
| 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 |
| DrMSShakila |
Ayothidoss Pandithar Hospital |
Room no 1
Department of Maruthuvam
National institute of Siddha
Tambaram Sanatorium
Kanchipuram
Kancheepuram
TAMIL NADU |
8681918617
04422381314
shakilav2010@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 |
Azhal Pandu (Iron deficiency anemia), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Chitramutti Nei |
4 ml of Chitramutti Nei will be given twice a day along with hot water for a period of 45 days |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Hb level less than normal range, For male : 7-12gms/d1{13-18gms/d1}. For female :7-11gms /d1{11.5-16.5gms/d1}. Patient willing to undergo blood investigation. Patient willing to sign the informed consent stating that he/she will conscientiously stick to the treatment during 48days but can opt out of the trial of his/her own conscious discretion. |
|
| ExclusionCriteria |
| Details |
Hypertension.pregnancy and lactation. presence of any associated severe systemic illness.(e.g. CA,RA) Endocrine disorder(Thyroid abnormality,Diabetes mellitus) Cardiac disease.Renal disease.Inherited defects (sickle cell anemia, Thalassemia,Aplastic anemia) Patient not willing to give blood sample. Epilepsy.Worm infestation. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome is mainly assessed by comparing the pre and post treatment Hemoglobin level, of the trial patient. |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcome is assessed by comparing the following parameters,before and after the treatment.reduction of clinical symptoms.changes in complete blood count.changes in serum ferritin level |
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)
|
12/01/2018 |
| 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="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
|
It is a single non randomized open - label trial to determine the efficacy and safety of Chitramutti nei in patients with Azhal Pandu (Iron deficiency Anemia). In this trial 40 Iron deficiency Anemia patients will be recruited and the trial drug will be administered 4 ml twice a day along with hot water for a period 45 days. During the study period all the study related data will be recorded and documented in a separate trail master file for each patients. During the trial period if any adverse effect will be noticed and referred to pharmacovigilance department in NIS and further management will also be given in NIS OPD and IPD. The entire trial will be monitored by the research monitoring committee of NIS. During this trial all the safety and 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 Indian Journal of Medical Research. |