| CTRI Number |
CTRI/2021/06/034391 [Registered on: 25/06/2021] Trial Registered Prospectively |
| Last Modified On: |
09/08/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Other |
|
Public Title of Study
|
The safety and efficacy of Ferric Pyrophosphate MR Tablets in female patients with iron deficiency anemia. |
|
Scientific Title of Study
|
A controlled open label parallel group study to demonstrate the safety and efficacy of Ferric Pyrophosphate MR Tablets in female patients with 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 |
Dr Almas Pathan |
| Designation |
Principal Investigator |
| Affiliation |
Jehangir Clinical Development Centre.Pvt.Ltd |
| Address |
Jehangir Hospital Premises 32 Sassoon Road
Pune
MAHARASHTRA
411001
India |
| Phone |
9763002830 |
| Fax |
|
| Email |
almas.jikare@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrMandar Kodgule |
| Designation |
Chairman and CEO |
| Affiliation |
NutraXceed Lifesciences Pvt. Ltd |
| Address |
SHOP NO 16, SHANTIKUNJ CHS. PLOT NO 14D SECTOR 04, KHARGHAR NAVI MUMBAI Raigarh
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9881062118 |
| Fax |
|
| Email |
mandar@iqgenx.com |
|
Details of Contact Person
Public Query
|
| Name |
DrMandar Kodgule |
| Designation |
Chairman and CEO |
| Affiliation |
NutraXceed Lifesciences Pvt. Ltd |
| Address |
SHOP NO 16, SHANTIKUNJ CHS. PLOT NO 14D SECTOR 04, KHARGHAR NAVI MUMBAI Raigarh
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9881062118 |
| Fax |
|
| Email |
mandar@iqgenx.com |
|
|
Source of Monetary or Material Support
|
| Jehangir Clinical Development Centre.Pvt.Ltd. |
|
|
Primary Sponsor
|
| Name |
NutraXceed Lifesciences Pvt Ltd |
| Address |
SHOP NO 16, SHANTIKUNJ CHS. PLOT NO 14D SECTOR 04, KHARGHAR NAVI MUMBAI Raigarh MH 410210 |
| Type of Sponsor |
Other [Manufacturing, Marketing, Distribution and Sales of Nutritional Product. ] |
|
|
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 |
| DrAlmas Pathan |
Jehangir Clinical Development Centre.Pvt.Ltd |
Ground floor Cabin 1, Jehangir Hospital Premises 32 Sassoon Road,Pune-411001
Pune
MAHARASHTRA |
9763002830
almas.jikare@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Ethics Committee,Jehangir Clincial Development Centre.Pvt.Ltd |
Approved |
| Ethics Committee,Jehangir Clinical Development Centre.Pvt.Ltd. |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D508||Other iron deficiency anemias. Ayurveda Condition: others, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NutraXceed’s Modified Release Ferric pyrophosphate |
Ferric pyrophosphate (soluble) equivalent to 30mg of elemental iron, 25mcg Cyanocobalamin (Vit B-12), 400mcg Folic acid
(One tablet OD for 12 weeks)
|
| Intervention |
NutraXceed’s Modified Release Ferric pyrophosphate |
Ferric pyrophosphate (soluble) equivalent to 30mg of elemental iron, 25mcg Cyanocobalamin (Vit B-12), 400mcg Folic acid
Two tablets OD for 12 weeks
|
| Comparator Agent |
OROFER® XT |
Ferrous Ascorbate Tablets equivalent to 100mg of elemental iron and 1.1 mg Folic acid (One tablet OD for 12 weeks) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
1.Signed and dated written informed consent is obtained prior to participation.
2.Female outpatients between 18 to 55 years of age and using effective method of contraception if sexually active.
3.Non-use of any iron supplement for 3 months prior to enrolment to the study.
4.Presence of iron deficiency anaemia: low haemoglobin (Hb 8-11.9 gm/dl) + low serum ferritin (≤ 15 mg/ml) and serum transferrin saturation saturation <20%.
5.Able to comply with the requirements of the protocol.
|
|
| ExclusionCriteria |
| Details |
A subject will not be eligible for inclusion in this study if ANY of the following criteria apply:
• Pregnancy (confirmed by urine dipstick method)
• Desire to conceive within the next 3 months including patients who are receiving treatment to facilitate conception.
• Lactating women.
• Medical history of current haematological disorders other than iron deficiency anemia, thyroid dysfunction, chronic renal disease or any other condition which may interfere with the study in the opinion of a Principal Investigator should be excluded.
• Inability to withhold prohibited medication.
• Obvious internal or external bleeding as documented by medical history and/or examination if considered clinically significant in the opinion of the investigator.
• Serious, uncontrolled disease (other than thyroid dysfunction and chronic renal disease) including serious psychological disorders likely to interfere with the study and/or likely to cause death within the study period.
• Participation in another clinical trial in the last 8 weeks before entry to Visit 0.
• Evidence of alcohol or drug abuse, that may, in the opinion of the investigator interfere with study compliance or prevent understanding of the objectives, investigational procedures or possible consequences of the study.
• Known or suspected hypersensitivity to iron or any of the components of Ferric Pyrophosphate MR Tablets or Orofer XT tablets.
• Patients with any other reason which may interfere with the study in the opinion of a Principal Investigator should be excluded
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean haemoglobin rise every 4 weeks up to 12 weeks in each Ferric Pyrophosphate MR tablets group (30 mg/day and 60mg/day tablets). |
Week 4, Week 8 ,Week 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean haemoglobin rise every 4 weeks up to 12 weeks in each Ferric Pyrophosphate MR tablets group (30 mg/day and 60mg/day tablets). |
week 12 |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
28/06/2021 |
| 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="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This will be a controlled open label parallel- group study. It is projected that the study will randomize 15 women (5 subjects in each treatment arm) with iron deficiency anemia (Hb 8-11.9 gm/dl + serum transferrin saturation <20%,serum and serum ferritin ≤ 15ng/ml). The rationale for conducting this study is to compare the safety and effectiveness of ferric pyrophosphate MR tablets in increasing Hb levels in iron deficiency anemia patients in comparison to Orofer-XT tablets |