| CTRI Number |
CTRI/2022/09/045556 [Registered on: 15/09/2022] Trial Registered Prospectively |
| Last Modified On: |
07/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Food Supplement ] |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
Tri-Fer and comparator, for 3-months of treatment for iron deficiency |
|
Scientific Title of Study
|
A Single Centeric Randomized Double Arm-Parallel, Open-label, Interventional, after administration of Tri-Fer and comparator, the subjects were observed for 3-months of treatment duration of establishment Mild hormonal imbalance related iron deficiency |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrGiriraja KV |
| Designation |
Principal Investigator |
| Affiliation |
Rajalakshmi Hospital |
| Address |
Rajalakshmi Hospital
General Medicine
Room No. 1
Lakshmipura Main Road, Vidyaranyapura post, Bangalore
Bangalore
KARNATAKA
560097
India |
| Phone |
080-23254855 |
| Fax |
|
| Email |
drgirirajkv@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrGiriraja KV |
| Designation |
Principal Investigator |
| Affiliation |
Rajalakshmi Hospital |
| Address |
Rajalakshmi Hospital
General Medicine
Room No. 1
Lakshmipura Main Road, Vidyaranyapura post, Bangalore
Bangalore
KARNATAKA
560097
India |
| Phone |
080-23254855 |
| Fax |
|
| Email |
drgirirajkv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrGiriraja KV |
| Designation |
Principal Investigator |
| Affiliation |
Rajalakshmi Hospital |
| Address |
Rajalakshmi Hospital
General Medicine
Room No. 1
Lakshmipura Main Road, Vidyaranyapura post, Bangalore
Bangalore
KARNATAKA
560097
India |
| Phone |
080-23254855 |
| Fax |
|
| Email |
drgirirajkv@gmail.com |
|
|
Source of Monetary or Material Support
|
| Stockshift India Pvt Ltd
Nale Plot., Datta Ngr,
Barshi - 413401,
Maharashtra, INDIA |
|
|
Primary Sponsor
|
| Name |
Stockshift India Pvt Ltd |
| Address |
Nale Plot., Datta Ngr,,
Barshi - 413401,
Maharashtra, INDIA
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 |
| DrGiri raja KV |
Rajalakshmi Hospital |
Rajalakshmi Hospital
General Medicine
Room No. 1
Lakshmipura Main Road, Vidyaranyapura post, Bangalore
Bangalore
KARNATAKA |
080-23254855
drgirirajkv@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rajalakshmi Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E611||Iron deficiency, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Iron Sulfate 500mg |
This medication is an iron supplement used to treat or prevent low blood levels of iron . Iron is an important mineral that the body needs to produce red blood cells and keep you in good health.
twice a day for 3 month |
| Intervention |
Tri-Fer
Capsules
|
This product is a combination complementary medicine which assists in iron deficiency anaemia associated with hormone imbalance in women.
twice a day for 6 month |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Subjects who meet the following criteria shall be considered eligible to participate in the
study:
1.Subjects of age group between 18-50 years of women’s are included in the study.
2.Female population.
3.A diagnostic of mild-moderate iron deficient anemia due to Mild Hormonal imbalance.
4.Already established Mild Hormonal imbalance (Tri-Fer as therapy).
5.Subjects who are willing to give informed consent without any hindrance are included in
the study. |
|
| ExclusionCriteria |
| Details |
1. Subjects below 18 years and above 60 years of age are excluded from the study.
2. Patients with anemia caused by conditions other than iron deficiency.
3. Patients with abnormal laboratory test values at screening.
4. Patients with liver, kidney or circulatory system disease.
5. Patients with a history or present illness that is a malignant tumor or autoimmune
disease.
6. Patients who underwent intravenous administration of an iron preparation,
administration of an erythropoiesis stimulation agent or blood transfusion within 8
weeks before the screening.
7. Patients who underwent oral administration of an iron preparation (including an over-the
counter drug or supplement) within 4 weeks before the screening.
8. Severe anemia or Hormonal imbalance.
9. Patients who are undergoing or undergone Hormonal therapy in last one year.
10. PregnancyShift
T R A N S F E R I N G V A L U E
Page 24
11. Subjects with gastro or duodenal ulcers and are also afflicted with dysphagia &
odynophagia are excluded from the study.
12. Subjects with persistent GI bleeding and frequent vomiting are excluded from the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary outcome will be hemoglobin-levels improvements, measured before and after 3
months of Therapy of Tri-Fer Against the iron sulphate |
3month, 6 Month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the hormonal imbalance improvement in the treatment period.
• To assess the hormonal imbalance under observation by hormonal questionnaire.
• To assess Global overall symptom scale.
• To assess Adverse events |
3month, 6month |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
N/A |
|
Date of First Enrollment (India)
|
19/09/2022 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A Multicentric, Randomized, Double Arm-Parallel, Open-label, Interventional for established Mild Hormonal imbalance related iron deficiency, after administration of IP and Comparator. A total of 50 subjects aged between 18-50 years with Mild-moderate iron deficient anemia due to Mild Hormonal imbalance participated in this study. Subjects with Mild-moderate iron deficient anemia due to Mild hormonal imbalance is allocated and provided to receive Tri-Fer fixed Dose capsules Bid for 6 months and take 1 capsule twice daily for period of 180 Days but assessment is conducted on 3 months ( 90 days ) on 3 visits during treatment duration. |