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CTRI Number  CTRI/2024/07/070555 [Registered on: 13/07/2024] Trial Registered Prospectively
Last Modified On: 08/07/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Screening 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Trial to determine the safety, efficacy and ease of use of Transdermal Application of Multi Nutrient Lotion 
Scientific Title of Study   An Open Label, prospective, Randomized, Placebo Controlled, Three-Treatment, Parallel, Comparative Trial to determine the safety, efficacy and ease of use of Transdermal Application of Multi Nutrient lotion manufactured by Murlikrishna Pharma Pvt. Ltd., India with standard Supportive Care Treatment infemale patients with mild Anemia 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Hema Divakar 
Designation  Senior Consultant Obygyn  
Affiliation  Medical Director - Divakars Speciality Hospital 
Address  Divakars Speciality Hospital, No.220, 9th cross road, 2nd Phase,J P Nagar, Bengaluru

Bangalore
KARNATAKA
560078
India 
Phone  9900154448  
Fax    
Email  drhemadivakar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Hema Divakar 
Designation  Senior Consultant Obygyn  
Affiliation  Medical Director-Divakars Speciality Hospital 
Address  Divakars Speciality Hospital, No.220, 9th cross road, 2nd Phase,J P Nagar, Bengaluru


KARNATAKA
560078
India 
Phone  9900154448  
Fax    
Email  drhemadivakar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Hema Divakar 
Designation  Senior Consultant Obygyn  
Affiliation  Medical Director - Divakars Speciality Hospital 
Address  Divakars Speciality Hospital, No.220, 9th cross road, 2nd Phase,J P Nagar, Bengaluru


KARNATAKA
560078
India 
Phone  9900154448  
Fax    
Email  drhemadivakar@gmail.com  
 
Source of Monetary or Material Support  
Murali Krishna Pharma Pvt Ltd. D-98, Ranjangaon MIDC, Ranajangaon Tal. Shirur, Dist. Pune, Maharshtra, India - 412 209 
 
Primary Sponsor  
Name  Murali Krishna Pharma Pvt Ltd 
Address  D-98, Ranjangaon Midc, Ranajangaon Tal. Shirur, Dist.Pune Maharashtra, India Pin-412 209 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Hema Divakar  Divakars Speciality Hospital  Divakars Speciality Hospital, No. 220, 9th cross road, 2nd Phase, JP nagar, Bengaluru - 560078
Bangalore
KARNATAKA 		 9900154448

drhemadivakar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Divakars Speciality Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  2. Iron deficiency anemia with low hemoglobin ranging from 9-10.9 g/dL at the onset of the study (at first visit). 
Patients  (1) ICD-10 Condition: D539||Nutritional anemia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Orofer XT  Folic Acid Tablets Dosage and Administration - 100 mg one tablet a day Time duration: 84 days +/- 2 days 
Intervention  Transdermal Liposomal Lotion  Product Description: Product containing API of Ferrous Bis Glycinate (Elemental Iron), Vitamin B12,Vitamin D3, Folic Acid Dosage and Administration: 5 ml - once a day. Time duration - 84 days+/- 2 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  Subjects meeting following criteria will be included in the study:
1. Female patients with age 18-50 years (both inclusive), residing in the study area.
2. Iron deficiency anemia with low hemoglobin ranging from 9-10.9 g/dL at the onset of the study (at first visit).
3. Patient is willing to give informed consent, able to provide availability for the entire study period and follow study protocol
 
 
ExclusionCriteria 
Details  1. Women or girls with significant co-morbidities including hemoglobinopathies.
2. Patients who have received blood or blood products transfusion during the current illness
3. Patients with generalized skin disorder hampering the regular application transdermal of investigational drug
4. Pregnant and lactating women
 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
300 study participants - To evaluate the efficacy of transdermal application of Multi nutrient Lotion for prevention of micronutrient deficiencies in mildly anemic women  (Day 84 ± 2 Day) (Week 12) 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the safety & tolerability of transdermal application of Multi nutrient Lotion for prevention of micronutrient deficiencies in mildly anemic women. Time points One year.   One year 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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)   22/07/2024 
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)   Open to Recruitment 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  Secure Data Repository, Data Access Agreement, Proposal Submission, Access Review, Data Availability Period

  6. For how long will this data be available start date provided 25-06-2024 and end date provided 25-06-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

STUDY TITLE: “A Triple-Blind, Prospective, Randomized, Placebo-Controlled, Three-Treatment, Parallel, Comparative Trial to determine the safety, efficacy and ease of use of Transdermal Application of Multi Nutrient Lotion manufactured by Murlikrishna Pharma Pvt. Ltd., India with Standard Supportive Care Treatment in  female patients with mild Anemia”.

Protocol No.

 

VRL-CT-23-020

Version No.

 

1.0

Date

 

22 Sep 2023

Principal Investigator

Dr. Hema Divakar

 

 

Screening period

After obtaining the informed consent, patients will be screened by undergoing various assessments as mentioned in Schedule of Assessment. The total duration of study   will be of 12 weeks, which excludes 3 week (maximum) of screening period.

The study consists of following visits:

·         Visit 1 (Day -21 to -1): Screening period

·         Visit 2 (Day 1): Randomization visit

·         Visit 3 (Day 28 ± 2 Day) (Week 4): Treatment visit

·         Visit 4 (Day 56 ± 2 Day) (Week 8): Treatment visit

·         Visit 5 (Day 84 ± 2 Day) (Week 12): End of Study visit

 

Eligible patients will be given either:

 

Arm A: Transdermal Liposomal Lotion of each 2.5 ml Contains Ferrous Bisglycinate (Elemental Iron 5 mg), Vitamin B12 (0.0004 mg), Vitamin D3 (0.01 mg) & Folic Acid (0.05 mg) 5ml single application once a day on the skin over the dorsum aspect of either forearm, preferably at same time daily for the entire study duration

 

Arm B: Ferrous bisGlycinate (Elemental Iron 30 mg), Zinc picolinate (Elemental Zinc 11 mg), Folic acid (0.5 mg) & Vitamin B12 (7.5 mcg) Tablets – one table orally once daily preferably at same time daily for the entire study duration

Arm C: Placebo Transdermal Liposomal Lotion - 5ml single application once a day on the skin over the dorsum aspect of either forearm, preferably at same time daily for the entire study duration

 

 

 
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