Health Condition 1: D67- Hereditary factor IX deficiency Health Condition 2: D66- Hereditary factor VIII deficiency
Conditions
Interventions
None listed
Sponsors
Dr. Shubham Ramnarayan Dhoot
R M Dhariwal Foundation
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age between 4 to 65 years (both inclusive). 2. Diagnosed with Hemophilia A or B (Factor VIII or IX deficiency), of mild, moderate, or severe type as per standard classification. 3. Currently receiving or eligible to receive standard care therapy (e.g., Clotting Factor VIII or IX). 4. Willing to take Raktamrut Vati as adjunct therapy along with standard treatment. 5. Parent/guardian consent (for participants under 18 years) or written informed consent from adult participants. 6. Willingness to comply with study procedures and follow-up schedule.
Exclusion criteria
Exclusion criteria: 1. Individuals with bleeding disorders other than hemophilia (e.g., von Willebrand disease, platelet function disorders). 2. History or presence of inhibitors Positive (antibodies) against Clotting Factor VIII or IX. 4. Presence of any other coagulation disorder or significant hematological, hepatic, renal, Neurological or cardiovascular disease. 4. Participation in another interventional clinical trial within the last 30 days. 5. Known hypersensitivity or allergy to any component of Raktamrut Vati or Clotting Factors. 6. Current use of unapproved or investigational herbal products or supplements that could interfere with study results. 7. Severe psychiatric illness or cognitive impairment that interferes with informed consent or compliance. 8. Any other condition, as per investigator s judgment, that may place the participant at undue risk or affect the validity of the study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in dose/frequency of Clotting Factor VIII/IX requiredTimepoint: Baseline to Day 180 | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction in frequency of bleeding episodesTimepoint: Baseline to Day 180;Improvement in Muscle and Joint Health Score (e.g., HJHS, FISH if used)Timepoint: Baseline, Day 90, Day 180 ;Improvement in Hemostatic ScoreTimepoint: Baseline, Day 90, Day 180;Quality of Life improvement (QoL)Timepoint: Baseline and Day 180;Reduction in intensity of Pain (by using VAS)Timepoint: Baseline to Day 180;Safety and tolerability of Raktamrut Vati Throughout studyTimepoint: up to Day 180;Hemoglobin and Hematocrit levelsTimepoint: Baseline, Day 90, Day 180;Improvement in Clotting TimeTimepoint: Baseline, Day 90, Day 180;Liver and renal function markers (SGOT, SGPT, Creatinine)Timepoint: Baseline and Day 180;Change in Plasma Level of Clotting FactorTimepoint: Baseline to Day 180 | — |
Countries
India
Contacts
Public ContactDr Shubham Ramnarayan Dhoot
Alchemy Clinical Research Services
Outcome results
None listed