| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D649||Anemia, unspecified. Ayurveda Condition: PANDUROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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. | | 2 | Intervention Arm | Drug | Classical | | (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. |