A double-blind, randomized, placebo-controlled trial of individualized homoeopathic medicines in reducing the lesion size of dorsal wrist ganglion in adults
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- The size (diameter and height) of the lesion, measured with slide calipers
研究概览
简要总结
Ganglion is a nodular tumor - like lesions or mucoid flesh, arising from tendon sheaths, ligaments, or joint capsule, especially of the hands, wrists, or feet. They are not true cysts as they lack epithelial wall. Dorsal wrist ganglion symptoms include discomfort, weakness, difficulty doing daily tasks, or a growth in size, patients typically seek medical attention etc., though the use of homoeopathic medicines is extensive globally to treat dorsal wrist ganglion, diligent research evidence in favour of homoeopathic is not well marked. So we intend to undertake the research to evaluate the efficacy and safety of homoeopathic medicines in the treatment of dorsal wrist ganglion. Thus, this double- blind , randomized (2:1), placebo – controlled, trail, using individualized homoeopathic medicines along with standard care will be conducted on 36 suffering from dorsal wrist ganglion in both the outpatient and inpatient departments of D. N. De homoeopathic medical collage & hospital. Primary outcome will be the changes in the size of the lesion of ganglion using digital slide calipers . Patient-Rated Wrist Evaluation( PRWS), Mayo Wrist Score( MWS), Measure Yourself Medical Outcome Profile (MYMOP - 2) will be the secondary outcome. All the outcome will be measured every month up to 6 months. Group differences will be analyzed statistically . Results will be published in scientific journal.
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
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients diagnosed with wrist ganglion (ICD-11 Code FB42.2) clinically and by USG.
- •Age 18- 65 years
- •Participants of either sex or transgender
- •Participants having prior experience or knowledge of the treatment.
- •e.g. primed to expect homoeopathic aggravation and available treatment options for the disease conditions, intimated through Patient Information Sheet.
排除标准
- •Not providing written informed consent of participation.
- •Non-ambulant patients.
- •Patient suffering from active or chronic, systemic or local infection or disease.
- •Patients who are too sick for consultation.
- •Unwilling to take part and not giving consent to join the study
- •Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life.
- •Pregnancy, puerperal women and lactating mother.
- •Tobacco chewing and/or smoking, alcoholism and/or any form(s) of substance abuse and/or dependence (TAPS tool) [21].
- •Undergoing homoeopathic treatment for any chronic disease within last 6 months.
- •Simultaneous participation in any other clinical trial.
结局指标
主要结局
The size (diameter and height) of the lesion, measured with slide calipers
时间窗: Baseline, every month, up to 6 months
次要结局
- PRWE- Patient-Rated Wrist Evaluation(Baseline, every month, up to 6 months)
- MWS- Mayo Wrist Score(Baseline, every month, up to 6 months)
- MYMOP-2- Measure Yourself Medical Outcome Profile(Baseline, every month, up to 6 months)
研究者
Dr R Raguram
D. N. De Homoeopathic Medical College and Hospital