A Prospective, Open-Label, Four-Arm, Parallel-Group Clinical Study to Evaluate the Efficacy and Safety of Raktamrut Vati as an Adjunct Therapy in Patients with Hemophilia.
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Reduction in dose/frequency of Clotting Factor VIII/IX required
研究概览
简要总结
This is a prospective, open-label, randomized, four-arm, parallel-group clinical study designed to evaluate the efficacy and safety of Raktamrut Vati as an adjunct therapy in patients with Hemophilia A or B. The study will enroll 100 male participants aged 4 to 65 years diagnosed with mild, moderate, or severe Hemophilia A or B. Each participant will be followed for a duration of 180 days, with visits scheduled as follows: a Screening Visit (Day –7 to Day 0), Randomization and Baseline Visit (Visit 1, Day 0), and four Follow-up Visits on Day 45 (Visit 2), Day 90 (Visit 3), Day 135 (Visit 4), and End of Treatment (Visit 5, Day 180).The primary outcome of the study is the reduction in cumulative clotting factor usage (International Units per month per patient) from baseline to Day 180, as recorded in patient infusion logs and verified through hospital records. Primary efficacy measures include: (1) total clotting factor consumption over 6 months, (2) number of clotting factor infusions required, and (3) time to first bleeding episode post-randomization Eligible participants will be randomized into four groups: Group 1 (Hemophilia B patients receiving standard treatment with Clotting Factor IX), Group 2 (Hemophilia B patients receiving standard treatment with Clotting Factor IX plus Raktamrut Vati), Group 3 (Hemophilia A patients receiving standard treatment with Clotting Factor VIII), and Group 4 (Hemophilia A patients receiving standard treatment with Clotting Factor VIII plus Raktamrut Vati). The allocation ratio within each hemophilia type will be 1:3 (control : intervention).
Secondary outcomes include: (1) frequency of bleeding episodes, (2) improvement in joint health score (e.g., Hemophilia Joint Health Score – HJHS), (3) changes in hematological parameters such as hemoglobin and hematocrit, (4) changes in liver and renal function tests (SGOT, SGPT, and serum creatinine), (5) improvement in quality of life assessed by validated hemophilia-specific QoL questionnaires (e.g., Haemo-QoL), and (6) Reduction of intensity of Pain (7) incidence and severity of adverse events related to the study intervention.
This study aims to assess whether the addition of Raktamrut Vati to standard factor replacement therapy can reduce clotting factor requirements and improve clinical outcomes without compromising safety in patients with Hemophilia.Raktamrut A Ray of Hope Powered by the Wisdom of Ayurvedic Science A Tablet of Strength for Every Warrior Living with Hemophilia
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 4.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Male
入选标准
- •Age between 4 to 65 years (both inclusive).
- •Diagnosed with Hemophilia A or B (Factor VIII or IX deficiency), of mild, moderate, or severe type as per standard classification.
- •Currently receiving or eligible to receive standard care therapy (e.g., Clotting Factor VIII or IX).
- •Willing to take Raktamrut Vati as adjunct therapy along with standard treatment.
- •Parent/guardian consent (for participants under 18 years) or written informed consent from adult participants.
- •Willingness to comply with study procedures and follow-up schedule.
排除标准
- •Individuals with bleeding disorders other than hemophilia (e.g., von Willebrand disease, platelet function disorders).
- •History or presence of inhibitors Positive (antibodies) against Clotting Factor VIII or IX.
- •Presence of any other coagulation disorder or significant hematological, hepatic, renal, Neurological or cardiovascular disease.
- •Participation in another interventional clinical trial within the last 30 days.
- •Current use of unapproved or investigational herbal products or supplements that could interfere with study results.
- •Severe psychiatric illness or cognitive impairment that interferes with informed consent or compliance.
- •Any other condition, as per investigator’s judgment, that may place the participant at undue risk or affect the validity of the study results.
结局指标
主要结局
Reduction in dose/frequency of Clotting Factor VIII/IX required
时间窗: Baseline to Day 180
次要结局
- Reduction in frequency of bleeding episodes(Baseline to Day 180)
- Improvement in Muscle and Joint Health Score (e.g., HJHS, FISH if used)(Baseline, Day 90, Day 180)
- Improvement in Hemostatic Score(Baseline, Day 90, Day 180)
- Quality of Life improvement (QoL)(Baseline and Day 180)
- Reduction in intensity of Pain (by using VAS)(Baseline to Day 180)
- Safety and tolerability of Raktamrut Vati Throughout study(up to Day 180)
- Hemoglobin and Hematocrit levels(Baseline, Day 90, Day 180)
- Improvement in Clotting Time(Baseline, Day 90, Day 180)
- Liver and renal function markers (SGOT, SGPT, Creatinine)(Baseline and Day 180)
- Change in Plasma Level of Clotting Factor(Baseline to Day 180)
研究者
Dr Shubham Ramnarayan Dhoot
Government Ayurvedic College, Dharashiv