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CTRI Number  CTRI/2023/07/055267 [Registered on: 17/07/2023] Trial Registered Prospectively
Last Modified On: 08/02/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical study to evaluate the safety and efficacy of study drug for iron repletion in adult male or female patients suffering with iron deficiency anaemia as supplement to the treatment. 
Scientific Title of Study   A double-blind, randomized, comparative clinical study to evaluate the safety and efficacy of study drug for iron repletion in adult male or female patients suffering with iron deficiency anaemia as supplement/adjuvant to the treatment. 
Trial Acronym  Anemia 
Secondary IDs if Any  
Secondary ID  Identifier 
VCR-CSP-23/001 ver1.0 dated 24May2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ambanna Gowda 
Designation  Consultant Physician 
Affiliation  Unitree Health Care Diagnostics 
Address  Unitree Health Care Diagnostics 38/1 Church Road Marappa Garden J C Nagar Bengaluru

Bangalore
KARNATAKA
560006
India 
Phone  9854270377  
Fax  -  
Email  unitreeclinicalresearch@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ambanna Gowda 
Designation  Consultant Physician 
Affiliation  Unitree Health Care Diagnostics 
Address  Unitree Health Care Diagnostics 38/1 Church Road Marappa Garden J C Nagar Bengaluru


KARNATAKA
560006
India 
Phone  9854270377  
Fax  -  
Email  unitreeclinicalresearch@gmail.com  
 
Details of Contact Person
Public Query  
Name  Shalini Dayananda 
Designation  Project Manager 
Affiliation  Vivatiq Clinical Research 
Address  358/274 Srigandha Nagar Main Road Hegganahalli Vishwaneedam Post (near Peenya Industrial Area 2nd stage)

Bangalore
KARNATAKA
560079
India 
Phone  9980107723  
Fax  -  
Email  vivatiqcr@gmail.com  
 
Source of Monetary or Material Support  
YourZooki Holdings Ltd.05 Garstang Road, Preston, Lancashire, United Kingdom 
 
Primary Sponsor  
Name  YourZooki holdings Ltd  
Address  05 Garstang Road, Preston, Lancashire, United Kingdom, PR1 1LD 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
na  na 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ambanna Gowda  Unitree Health Care Diagnostics   38/1 Church Road, Marappa Garden J C Nagar Bengaluru 560006
Bangalore
KARNATAKA 		 9845270377
-
unitreeclinicalresearch@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ACE Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:D509||Iron deficiency anemia, unspecified. Ayurveda Condition: RAKTASTHITAKAPAKOPAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Liposomal Iron Liquid, Reference: NA, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 4 Weeks, anupAna/sahapAna: No, Additional Information: Liposomal Iron Liquid sachet - 20 mg elemental iron per sachet
2Comparator Arm (Non Ayurveda)-conventional iron supplementConventional Iron supplement- Oral administering content of 1 sachet (10 ml) in 250 ml water.
3Comparator Arm (Non Ayurveda)-Placebostudy IP without elemental iron - Orally administering content of 1 sachet (10 ml) in 250 ml water.
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients of either gender 18 to 70 years (inclusive)
Subjects giving written informed consent /assent form
Patients having presence of iron deficiency anemia below normal or low hemoglobin as per lab reports.

Non-use of any iron supplement for 2 weeks prior to enrolment to the study and to know the dosage timing of Calcium supplement if any.

Willing to come for regular follow-up visits.

In the opinion of the investigator, able to comply with the requirements of the protocol.

 
 
ExclusionCriteria 
Details  Patients with serious cardiovascular, cerebro-vascular respiratory liver or renal disease or any other disorder.

Known history of hypersensitivity to herbal extracts or dietary supplements. Known or suspected hypersensitivity to iron or any of the components of Investigational Product.

Pregnant women, lactating women and women of child bearing potential not following adequate contraceptive measure, women who were found positive for urine pregnancy.

Medical history of current hematological disorders other than iron deficiency anemia (e.g. aplastic anemia, megaloblastic anemia, sideroblastic anemia, pernicious anemia, thalassemia, sickle cell anemia, etc.).

Evidence of alcohol or drug abuse, that may, in the opinion of the Investigator interferes with study compliance or prevents understanding of the objectives, investigational procedures or possible consequences of the study.
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in hematological parameters CBC RBC indices from baseline to Day 15 Day 30  Day 15 Day 30 
 
Secondary Outcome  
Outcome  TimePoints 
Change in quality of life (QoL assessed by SF-36) from baseline to Day 15 Day 30  Day 15 Day 30 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   26/07/2023 
Date of Study Completion (India) 10/11/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
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   Iron is unique among nutrients in being both essential and highly toxic. Anemia is a public health problem affecting about a third of the world’s population both in developing and in developed countries. It is known to occur at all stages of life; children aged.Liposomes are spherical vesicles characterized by a bilayer of lipids with an internal aqueous cavity. Liposome structural components are phospholipids. This phospholipid bilayer is suitable for fundamental cellular functions, such as motility and shape change, and provides the ability to mimic the biophysical properties of living cells. Liposomes are biphasic and therefore render them the ability to act as carriers for both lipophilic and hydrophilic drugs. Encapsulation of drugs in liposomes enhanced the therapeutic indices of various agents. The liposomal protection allows the iron to overcome the free gastric environment, preventing early degradation of the substance and/or its inactivation and to be absorbed directly. This mechanism provides liposomal iron a greater availability, reduces gastrointestinal side effects, and prevents iron instability in the gastrointestinal tract from being directly absorbed into the intestine and directly liberated into the liver. Consequently, this method of iron supplementation is associated with high gastrointestinal absorption, high bioavailability, and a low incidence of side effects.

 
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