CTRI/2025/09/094251尚未招募2/3 期
A series of N-of-1 trials exploring the efficacy of individualized homoeopathic medicines in LM potencies along with standard of care in the treatment of resistant hypertension in post-menopausal women.
D.N.De Homoeopathic Medical College and Hospital Government of West Bengal1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2025年9月14日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Difference in systolic blood pressure (SBP) and diastolic blood pressure (DBP)
研究概览
简要总结
| This study is designed whether IHMs in LM Potencies can produce any significant effect beyond placebo in systolic and diastolic blood pressures in the treatment of resistant hypertension in postmenopausal women after four months of intervention, using an N-of-1 trial design. The trial will be conducted at the Outpatient Department of D. N. De Homoeopathic Medical College and Hospital, Kolkata. Participants will receive personalized homeopathic medicines, with each treatment cycle followed by a washout phase to assess individual responses. The primary outcome is the change in systolic and diastolic blood pressure from baseline. Secondary outcomes include improvement in quality of life measured by the MINICHAL (Mini Cuestionario de Calidad de Vida en Hipertensión Arterial) and SF-12 (Short Form Health Survey) scales. Additionally, ancillary investigations—including serum urea, serum uric acid, serum creatinine, urine routine examination, lipid profile, and electrocardiogram (ECG) will be conducted to monitor end-organ damage associated with hypertension. This trial aims to assess the individualized therapeutic response to homeopathy in resistant hypertension and explore its potential as a safe, complementary approach in long-term hypertension care. |
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 45.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •Postmenopausal women with age group of 45-60 yrs of age.
- •Diagnosed cases of essential hypertension with blood pressure range, Systolic: 140- 159mmhg, Diastolic: 90-99mmhg
- •Patients on concurrent use of antihypertensive medications.
排除标准
- •Failing to give written, informed consent/assent before participating
- •Postmenopausal Hypertension cases associated with complications like kidney disease, heart diseases, stroke etc.
- •and severe concurrent illness
- •Cases with autoimmune disorders
- •Cases with substance abuse and /or dependence.
- •Patient undergoing any hormonal replacement therapy, using contraceptive pills or history of their use in previous 3 months.
- •Those who are too ill to get consultation.
- •Diagnosed cases of uncontrolled or potentially fatal illnesses impacting quality of life, such as unstable mental or psychiatric illnesses.
- •Receiving homoeopathic treatment within the last six months for any chronic illness.
- •Concurrent involvement in any other clinical study.
结局指标
主要结局
Difference in systolic blood pressure (SBP) and diastolic blood pressure (DBP)
时间窗: At Baseline every 17 days up to 4 months
次要结局
- Mini Questionnaire of Quality of Life in Hypertension (MINICHAL) Questionnaire(At Baseline every 17 days up to 4 months)
- Medical Outcomes Study Questionnaire Short Form 12 (SF-12) Questionnaire(At Baseline every 17 days up to 4 months)
- Serum Urea, uric acid, creatinine, urine R/E, Lipid profile & ECG(At Baseline every 17 days up to 4 months)
研究者
Urvashi Diwakar
D.N.De Homoeopathic Medical College and Hospital Government of West Bengal
研究点 (1)
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