跳至主要内容
临床试验/CTRI/2023/11/060229
CTRI/2023/11/060229招募中3 期

Efficacy of individualized homoeopathy in treatment of primary dysmenorrhea in adolescents:a randomized, double blind, placebo-controlled trial.

Central Council for Research in Homoeopathy3 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年1月12日最近更新:

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
120
试验地点
3
主要终点
Number of pain days in Homoeopathic group as compared to placebo group over 6 months.

研究概览

简要总结

Dysmenorrhea is one of the most common gynaecological problems and is characterized by acute pelvic pain during menstruation. Primary dysmenorrhea is the presence of painful menstruation in the absence of pelvic diseases (e.g., endometriosis and pelvic inflammatory disease) or pelvic leiomyoma. Primary dysmenorrhea is the most common form of chronic pelvic pain that can last for at least 6 months, can be severe enough to disrupt one’s daily life activities, and ultimately lead to medical or surgical treatment. The reported prevalence of dysmenorrhea has ranged from 15.8% to 89.5%, with higher rates reported in adolescent populations. It is the leading women hood problem that affects 90% of adolescent girls and more than 50% menstruating women. Prior studies have shown the impact of dysmenorrhea on quality of life as dysmenorrhea often leads to women not attending school or office. The rate of absence days from school was reported to vary between 14% and 51% among women with dysmenorrhea. The conventional treatment for primary dysmenorrhea is Nonsteroidal anti-inflammatory medications (NSAIDs) and oral contraceptives, but it has lot of side effects. As a result, patients seek complementary and alternative therapies, such as Homoeopathy as a treatment option for Primary dysmenorrhea and in Homoeopathic literature, myriads of drugs have been mentioned for Primary dysmenorrhea. This research study is planned to be carried out to obtain scientific evidence of the effectiveness of homeopathy in in reducing the pain days in Primary Dysmenorrhea in adolescents with an added benefit of knowing the efficacy of homoeopathy in reducing the use of analgesics for dysmenorrhea as well as improving the sick days or days of absenteeism in a student life.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
13.00 Year(s) 至 19.00 Year(s)(—)
性别
Female

入选标准

  • 1.Patients conformed to the diagnostic criterion of Primary Dysmenorrhoea according to the Primary Dysmenorrhea Consensus Guidelines and if they had experienced primary dysmenorrhoea for two or more months.
  • 2.Age between 13 to 19 years.
  • 3.Menstrual cycle(21 to 35) days.
  • 4.Pain on numeric rating scale (NRS)>
  • 5.Signed informed consent of the parent and assent of the children.

排除标准

  • 1.Secondary dysmenorrhea caused by endometriosis, uterine myoma, endometrial polyps, pelvic inflammatory disease, or other gynecological problems confirmed by a gynecological, abdominal ultrasound examination.
  • 2.Females with irregular/infrequent menstrual cycles (outside of the typical range 21 to 35 day’s cycle) 3.Patients with haemoglobin less than 7gm/dl.
  • 4.Patients complicated with severe diseases (e.g. cerebral, liver, kidney, systemic diseases, mental disorders) 5.Received other alternative therapies such as massage, acupressure, herbal therapy in the previous one month.
  • 6.Those who have been treated with hormone drugs over the last 3 months.
  • 7.poor treatment compliance (e.g. unstable working and living situation, difficult follow-up).

结局指标

主要结局

Number of pain days in Homoeopathic group as compared to placebo group over 6 months.

时间窗: At baseline and then every month over 6 months

次要结局

  • To evaluate the reduction in consumption of analgesics over 6 months.(At baseline and then every month over 6 months)
  • To evaluate the changes in scores of Menstrual distress questionnaire (MDQ) at 3rd and 6th month.(At baseline, 3rd and 6th month.)
  • To evaluate the change in intensity of pain of dysmenorrhea on numeric rating scale over 6 months.(At baseline and then every month over 6 months)
  • To evaluate the changes in working ability, location, intensity, days of pain, dysmenorrhea (WaLIDD) score over 6 months.(At baseline and then every month over 6 months)
  • To evaluate the changes in mean number of reporting absenteeism days from school/work over 6 months.(At baseline and then every month over 6 months)

研究者

发起方
Central Council for Research in Homoeopathy
申办方类型
Research institution

研究点 (3)

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