To Study the Effects of Raktamrut Vati in Haemophilia

To Evaluate Safety and Efficacy of Raktamrut Vati in Hemopholia - NIL

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/01/079406

Enrollment

120

Registered

2025-01-24

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: D67- Hereditary factor IX deficiency Health Condition 2: D66- Hereditary factor VIII deficiency

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Diagnosis of Hemophilia:- Participants must have a confirmed diagnosis of hemophilia A or B. 2. Severity level (mild, moderate, severe) 3. Age Range: 4 to 60 year 4. Treatment History: - Previous or ongoing treatment with clotting factor concentrates.

Exclusion criteria

Exclusion criteria: 1. Other Bleeding Disorders: - Exclude individuals with bleeding disorders other than haemophilia. 2. Severe Co-morbid Conditions: - Exclude participants with severe cardiovascular, renal, or neuro disease, unless these are specifically being studied. 3. Recent Participation in Other Clinical Trials: - Participants who have taken part in another clinical trial within a certain period (e.g., the last 30 days) may be excluded (e.g pt with prophylaxis treatment). 4. Allergies to Study Medications: - Exclude individuals with known allergies to the medications or interventions being tested.

Design outcomes

Primary

Measure	Time frame
1. Reduction in Clotting Factor Requirement Measure the percentage reduction in the need for external clotting factor concentrates following the administration of Raktamrut Vati over 6 Month. Measure Number of clotting factor units required per week. 2. Improvement in Clotting Time Evaluate the enhancement in the natural clotting process Measure Change in APTT. 3. Reduction in Bleeding Episodes Measure: Number of bleeding episodes per month and bleeding duration.Timepoint: 6 to 24 Weeks	—

Measure

Time frame

1. Reduction in Clotting Factor Requirement Measure the percentage reduction in the need for external clotting factor concentrates following the administration of Raktamrut Vati over 6 Month. Measure Number of clotting factor units required per week. 2. Improvement in Clotting Time Evaluate the enhancement in the natural clotting process Measure Change in APTT. 3. Reduction in Bleeding Episodes Measure: Number of bleeding episodes per month and bleeding duration.Timepoint: 6 to 24 Weeks

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Secondary

Measure	Time frame
Bleeding Control Reduction in Frequency Decrease in the number of bleeding episodes. Resolution Cessation of bleeding after treatment. Speed of Recovery Time taken for the bleed to stop after treatment administration. By decreasing the bleeding time of patients Hazardous complications will be decreased by reducing bleeding time & living a better life. Joint Health Improvement Pain Reduction Decreased pain in previously affected joints. Reduced Swelling Less swelling & inflammation in joints. Improved Range of Motion Better joint mobility & decreased stiffness. Absence of New Hemarthrosis No new bleeding in joints. General Well being Increased Energy Levels Reduction in fatigue & improved overall strength. Better Physical Activity Tolerance Ability to engage in daily activities with less limitation. Quality of LifeTimepoint: 6 weeks to 3 years	—

Measure

Time frame

Bleeding Control Reduction in Frequency Decrease in the number of bleeding episodes. Resolution Cessation of bleeding after treatment. Speed of Recovery Time taken for the bleed to stop after treatment administration. By decreasing the bleeding time of patients Hazardous complications will be decreased by reducing bleeding time & living a better life. Joint Health Improvement Pain Reduction Decreased pain in previously affected joints. Reduced Swelling Less swelling & inflammation in joints. Improved Range of Motion Better joint mobility & decreased stiffness. Absence of New Hemarthrosis No new bleeding in joints. General Well being Increased Energy Levels Reduction in fatigue & improved overall strength. Better Physical Activity Tolerance Ability to engage in daily activities with less limitation. Quality of LifeTimepoint: 6 weeks to 3 years

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Countries

India

Contacts

Public ContactDr Shubham Ramnarayan Dhoot

Government Ayurved College, Dharashiv

sdhoot1008@gmail.com8975656999

Outcome results