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CTRI Number  CTRI/2025/01/078934 [Registered on: 17/01/2025] Trial Registered Prospectively
Last Modified On: 09/10/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A Study to Test the Safety and Benefits of Hb Vista Ayurvedic Capsule for Anemia. 
Scientific Title of Study   An Open-Label, Single-Arm, Single-Centered Clinical Study To Evaluate The Safety And Efficacy Of Hb Vista Ayurvedic Capsule In Patients With Anaemia.  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
CTSRS/2421 Version No 1.0 Dated 05 Oct 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sambashiva 
Designation  Principal Investigator 
Affiliation  Sri Lakshmi Super Speciality Hospital 
Address  Room number 1, 5th floor clinical research room 301, 3rd Main Rd, near Indane Gas, V B Layout, Old Extension, Krishnarajapuram, Bengaluru, Karnataka 560036 Bangalore KARNATAKA

Bangalore
KARNATAKA
560049
India 
Phone  6364898825  
Fax    
Email  pi.clinicaltrial@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Ms Sathyavathi LM 
Designation  HOD Clinical Operations 
Affiliation  SAMAHITHA RESEARCH SOLUTIONS 
Address  Clinical Research Unit, No.1204, "Ashva", 2nd Floor, 26th Main, Jayanagar 9th Block, Bangalore

Bangalore
KARNATAKA
560091
India 
Phone  9739001749  
Fax    
Email  satyalm@samahitha.com  
 
Details of Contact Person
Public Query
 
Name  Ms Arpita Malgi 
Designation  Team Lead Clinical Operations  
Affiliation  Samahitha Research Solutions 
Address  Clinical Research Unit, No.1204, "Ashva", 2nd Floor, 26th Main, Jayanagar 9th Block, Bangalore

Bangalore
KARNATAKA
560069
India 
Phone  06364898825  
Fax    
Email  arpita@samahitha.com  
 
Source of Monetary or Material Support  
Ram Swaroop Pharmacy Village Bajada Pahari, Teh-Hathin District Palwal, Haryana - 121103 
 
Primary Sponsor  
Name  Ram Swaroop Pharmacy 
Address  Village Bajada Pahari, Teh-Hathin District Palwal, Haryana - 121103 
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 Sambashiva A C  Sri Lakshmi Super Speciality Hospital  Room number 1, 5th floor clinical research room 301, 3rd Main Rd, near Indane Gas, V B Layout, Old Extension, Krishnarajapuram, Bengaluru, Karnataka 560036 Bangalore KARNATAKA
Bangalore
KARNATAKA 
6364898825

pi.clinicaltrial@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Pranav Diabetes Center Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:D649||Anemia, unspecified. Ayurveda Condition: PANDUROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: HB Vista, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 6 Months, anupAna/sahapAna: No, Additional Information: -All participants will receive HB Vista for a duration of 6 months. For other that severe anemia conditions, the dosage is 1 capsule, taken twice daily before meals with water or lime water.
2Intervention ArmDrugClassical(1) Medicine Name: HB Vista, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 6 Months, anupAna/sahapAna: No, Additional Information: -The study will enroll 60 subjects diagnosed with anaemia. All participants will receive HB Vista for a duration of 6 months. For cases of severe anemia (≤8 mg/dL), the dosage is 1 capsule, taken three times daily before meals with water or lime water (nimbu pani) in the morning, afternoon, and evening.
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Patients of either sex, aged 18 to 65 years.
2.Patients diagnosed with anaemia and haemoglobin levels lessthan 12 g per dL for women and lessthan 13g perdL for men.
3. Willingness to provide informed consent and comply with all study procedures.
4. Ability to attend study visits and follow the treatment plan.
5. General Health: Patients in generally stable health, with anaemia as their primary condition
Mainly severe anemia cases.
 
 
ExclusionCriteria 
Details  1. Pregnancy and Lactation Pregnant or lactating women are excluded due to safety concerns.
2. Severe Anaemia Patients with a history of chronic or congenital anaemia.
3. Recent Transfusions Patients who have undergone blood transfusions within the past three
months.
4. Systemic Diseases Patients with systemic diseases like uncontrolled hypertension, uncontrolled
diabetes, or tuberculosis.
5. Allergies Known allergies or hypersensitivity to any of the ingredients in HB Vista.
6. Concomitant Diseases Patients with other severe medical conditions that could interfere with the
study outcomes or pose a risk to patient safety 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in haemoglobin concentration is in g per dL from baseline to the end of the study period.
The main outcome measure will be the increase in haemoglobin levels in patients from the
start to the completion of treatment.  
Day0, Day1,Day20, Day40, Day60  
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in Quality of Life is Measured using a validated QoL scale to be
defined, capturing patient-reported outcomes related to well-being, energy levels, and ability to perform daily tasks. 
Day0, Day1,Day20, Day40, Day60  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   28/01/2025 
Date of Study Completion (India) 11/07/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Introduction and Background:

Anaemia is recognized as a common clinical condition characterized by reduced haemoglobin levels or red blood cell count, leading to diminished oxygen-carrying capacity and symptoms such as fatigue, weakness, and dizziness. It commonly occurs due to nutritional deficiencies, chronic illnesses, or genetic disorders. Conventional treatments, although effective, are often associated with gastrointestinal side effects or do not address the underlying causes in all patients. HB Vista Ayurvedic Capsule is a polyherbal formulation containing Emblica officinalis (Amla), Phyllanthus niruri (Bhumi Amla), Kasis Bhasma, and Mandur Bhasma, which has traditionally been used in Ayurveda for their haematinic, iron-enhancing, and liver-supportive properties. Although the product is available in the market, systematic clinical evidence regarding its efficacy and safety in anaemic patients is lacking.

Purpose of the Study:

The primary purpose of this open-label, single-arm, single-centered clinical study was to evaluate the safety and efficacy of HB Vista Ayurvedic Capsule in patients with anaemia. The study assessed the change in haemoglobin concentration from baseline to the end of the treatment period, evaluated improvements in patients’ quality of life using a validated QoL scale, and monitored adverse events throughout the study. This post-marketing clinical trial aimed to generate scientific evidence supporting the use of HB Vista as a safe and effective Ayurvedic treatment for anaemia.

Summary of Results:

The clinical study evaluated the safety and efficacy of HB Vista Ayurvedic Capsule in 60 anaemic patients over a 60-day period. All enrolled subjects completed the study, with no dropouts or withdrawals. The study enrolled 38 female and 22 male Subjects. The primary efficacy endpoint demonstrated a statistically significant increase in mean haemoglobin levels from 6.09 g/dL at baseline to 13.05 g/dL at Day 60 (p < 0.00001), which was a steady and significant rise reflecting a 95.8% improvement. This indicated a strong and consistent haematinic effect of the intervention.

Secondary outcomes showed substantial improvements in quality of life (QoL) across physical, emotional, social, and occupational domains. Participants reported increased energy, reduced physical discomfort, enhanced emotional well-being, improved social engagement, and greater satisfaction with work and daily responsibilities. The average self-assessment of overall physical health showed a significant improvement and number of Subjects who could perform their daily activities without difficulty increased from 9 to 30. Reports of Physical Discomfort dropped sharply and all the Subjects acknowledged improved health condition. Similarly, there was positive shift in emotional wellness and reduced psychological distress with enhanced quality of life in Subjects. Also, the study demonstrated enhanced social activities by the Subjects, greater connection with others and increased satisfaction in personal relationships by the end of the study. The work-life balance also improved with none of the Subjects reporting missing work due to health issues at the end of the study. The study also reported significant improvements in complete blood count (CBC) parameters, including RBC, MCV, MCH, and MCHC levels, indicating improved red blood cell production and oxygen-carrying capacity.

No adverse events (AEs) or serious adverse events (SAEs) were reported throughout the study period. Liver and renal function parameters remained within normal ranges, and lipid profile analysis showed beneficial shifts in HDL, LDL, and triglyceride levels. The study reported 100% treatment compliance among participants.

These results confirmed that HB Vista Ayurvedic Capsule is both safe and effective in the management of anaemia and significantly improved patients’ overall quality of life.

 
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