| CTRI Number |
CTRI/2024/11/077400 [Registered on: 27/11/2024] Trial Registered Prospectively |
| Last Modified On: |
05/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Bjain Omeo Anemia Syrup in patients with Anemia |
|
Scientific Title of Study
|
A pilot study to evaluate the efficacy of Bjain Omeo Anemia Syrup in patients with Anemia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MGCTS/24/594H Version 1.0 dated 15 June 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Poornima Kaushal |
| Designation |
Principal Investigator |
| Affiliation |
CCFT Laboratories |
| Address |
1st Floor room 3, Skin testing lab , CCFT laboratories, AR multispecialty hospital and research center, Delhi Road
Meerut
UTTAR PRADESH
250002
India |
| Phone |
7455086734 |
| Fax |
|
| Email |
drpoornimakaushal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Puneet Mittal |
| Designation |
Clinical Research Consultant |
| Affiliation |
CCFT Laboratories |
| Address |
1st Floor room 3, Skin testing lab , CCFT laboratories, AR multispecialty hospital and research center, Delhi Road
Meerut
UTTAR PRADESH
250002
India |
| Phone |
8937015757 |
| Fax |
|
| Email |
puneetmittal@mgcts.org |
|
Details of Contact Person
Public Query
|
| Name |
Puneet Mittal |
| Designation |
Clinical Research Consultant |
| Affiliation |
CCFT Laboratories |
| Address |
1st Floor room 3, Skin testing lab , CCFT laboratories, AR multispecialty hospital and research center, Delhi Road
Meerut
UTTAR PRADESH
250002
India |
| Phone |
8937015757 |
| Fax |
|
| Email |
puneetmittal@mgcts.org |
|
|
Source of Monetary or Material Support
|
| BJAIN PHARMACEUTICALS Pvt. Ltd., A-98, A Block, Sector 63, Noida, Uttar Pradesh 201307 |
| CCFT Laboratories, 135, Punjabipura, Delhi Road, Meerut, India, 250002 |
|
|
Primary Sponsor
|
| Name |
BJAIN PHARMACEUTICALS Pvt. Ltd. |
| Address |
A-98, A Block, Sector 63, Noida, Uttar Pradesh 201307
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Poornima Kaushal |
CCFT laboratories |
Ground floor, Dr. Poornima’s Clinic (Homeopathy)
Meerut
UTTAR PRADESH |
7455086734
drpoornimakaushal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ARMHRC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Volunteers with diet deficient Anemia |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bjain Omeo Anemia Syrup |
Test Product: Bjain Omeo Anemia Syrup, Dose: Syrup (2tsp BD) orally twice a day for the durationof 60 days.
Route of administration: Oral, Duration: 60 days |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects of either gender- male or female of age 18-55.
2.Healthy subjects with reported diet deficient Anemia of any grade - Mild: Hemoglobin 10.0 g/dL to lower limit of normal. Moderate: Hemoglobin 8.0 to 10.0 g/dL. Severe: Hemoglobin 6.5 to 7.9 g/dL
3. Having signed a Consent Form.
4.Should be able to read and write (in English, Hindi or local language).
5. Having valid proof of identity and age. |
|
| ExclusionCriteria |
| Details |
1. Being pregnant or breastfeeding or having stopped to breastfeed in the
past three months
2. Having refused to give her assent by not signing the consent form
2. Taking part in another study liable to interfere with this study
2. Anemia related to any known Chronic disease
3. Having cutaneous hypersensitivity
4. Following a chronic or intermittent medicinal treatment comprising
any of the following products: aspirin-based products, antiinflammatories, anti-histamines, anti-coagulants, corticotherapy, taken
by general or local routes (the only medication permitted is
paracetamol)
5. Having undergone a surgery requiring a general anaesthetic of more
than one hour in the past 6 months |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1, % Change in Hemoglobin
2. % Change in Serum Iron |
Day 0, Day 30, day 60 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="6"
Sample Size from India="6"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
09/12/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Test Product: Bjain Omeo SyrupRoute of Duration: Syrup orally twice a day Test Druartion: 60days Objective is to study the efficacy : • Change in Haemoglobin, • Change in Iron levels |