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临床试验/CTRI/2024/06/068662
CTRI/2024/06/068662尚未招募不适用

A prospective experimental study to know the effectiveness of jonosia asoka in the cases of primary dysmenorrhoea with the help of WALIDD score

Rajkot Homoeopathic Medical College1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年10月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
To understand the effectiveness of jonosia asoka in the cases of primary dysmenorrhoea with the help of WALIDD Score

研究概览

简要总结

Normally life stage of typical women is divided into infancy, puberty(adolescence), sexual maturation (reproductive age), climacteric period and post climacteric period(elderly).

 Puberty being developmental period where hormonal, psychological and physical change occurs simultaneously; menarche being the first menstrual period in females that typically occurs between the age of 10 -16 years with the average age of onset being 12.4 years. (1)

 The determinants of menarchial age are socioeconomic condition, genetics, general health, nutritional status, exercise and family’s science.

 Menarche tends to be painless and occurs without warning when the first cycle is usually anovulatory with varied length and flow. Menarche indicates the biggening of reproductive life and closely associated with the ongoing development of secondary sexual characteristics.

 Menarche occurs in setting of a maturing normal hypothalamic-pituitary-ovarian axis, normal female reproductive anatomy, good nutrition and absence of any other chronic illness.

 It is a symbol of normal reproductive health and wellness; almost all females accept menarche as their body’s critical communication of fertility. When the females suffer with lot of pain during menstrual cycle, they don’t convey it or ignore it or he consider it as a part of life.

 Primary dysmenorrhoea is defined as pain during menstrual cycle in the absence of any other recognisable cause and it is the most common cause of pelvic pain.

 The impact of primary dysmenorrhea ranges from 45% - 95% in females of reproductive age group worldwide where 2%-29% females experience severe pain and a greater prevalence about 70%- 90% is generally reported in younger females. (1)

 Primary dysmenorrhoea negatively affects females’ quality of life and interferes with daily activities. The pathophysiology of primary dysmenorrhoea is likely a result of the cyclooxygenase pathway that increase prostanoids particularly prostaglandins. The high level of prostaglandins causes uterine contraction that restrict the blood flow and leads to the production of anaerobic metabolites that stimulates pain receptors.

 Females with the typical history of primary dysmenorrhoea starts with the empirical treatment that includes pain relieving medications, anti-inflammatory medications, rarely oral combined contraceptive pills, heat application (hot water bag), and regular exercise.

 Primary dysmenorrhoea is not only a physical issue but it’s a psychosocial issue affecting the life of females. Psychosocial issue in the sense of various orthodox thoughts, beliefs that are followed in the society, their impact on an immature teenager girl makes her more non communicable, antisocial, emotionally vulnerable, and also affects her intellectual skills and abilities.

 The empirical method of taking medications like pain killers, anti-inflammatory or oral combined contraceptive pills have pros and cons, if we focus on the cons they have a bad effect on the individual in the form of constipation, stomach discomfort, bleeding problem, abnormal weight gain, hepatotoxicity, body swelling etc…

 So, this being a psychosocial issue in females of vulnerable age group, can homoeopathy help them out?

 According to WHO the definition of health is “a complete state of physical, mental and social well-being and not merely the absence of disease.” (2)

 Homoeopathy is a scientific and effective system of holistic healing having a concept of like cures like.

Conventional system works only on the particular part of the body and not on whole body but homoeopathy considers the whole person that is mind, body, emotion. Homoeopathy is system of medicine giving importance to diseased individual rather than disease itself.

 India is one of the developing countries and very rich in forest and mineral resources. Native medicines of this countries are being ignored as they fail to assess their worth of native herbs under the influence of western drugs.

 Jonosia asoka plant has important place in Indian culture and it is described in charka Samhita that the effect of Jonosia asoka also known as saraca indica, empirically it was used as analgesic. Jonosia asoka plant has alkaloid - tannin and catechin which has its action on uterus, it lowers the prostaglandin levels that are secreted by endometrial lining during menstruation.

 As mentioned in HPI volume-1 Jonosia asoka has widespread action on female reproductive system; it is a great uterine tonic with efficacy in uterine and menstrual disorders. (3)(7)(9)(10)

As Jonosia asoka is known for its action in primary dysmenorrhoea but its infrequent use makes its efficacy less known so I had made an attempt to understand it in detail by using it as a uterine tonic for females suffering with this condition and help the community for the same.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

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

入选标准

  • nulliparous females.
  • females having no pelvic pathology.
  • age group since menarche to 19 years of age.
  • females having regular menstrual cycle.

排除标准

  • females having any pelvic pathology.
  • case of secondary dysmenorrhoea are to be excluded.
  • females above age of 19 years are to be excluded.
  • patients on OC pills or any other mode of treatment.

结局指标

主要结局

To understand the effectiveness of jonosia asoka in the cases of primary dysmenorrhoea with the help of WALIDD Score

时间窗: There will be some improvement after prescribing homoeopathic medicine which will be assessed after 4 weeks

To improve the quality of life of the women suffering from primary dysmenorrhea.

时间窗: There will be some improvement after prescribing homoeopathic medicine which will be assessed after 4 weeks

Clinical verification of symptoms of primary dysmenorrhoea in adolescent age group.

时间窗: There will be some improvement after prescribing homoeopathic medicine which will be assessed after 4 weeks

To assess the clinical utility of WALIDD score.

时间窗: There will be some improvement after prescribing homoeopathic medicine which will be assessed after 4 weeks

次要结局

  • Significant outcome: patient with sense of well being with decrease in score between 1-4.(Moderate improvement: patient wity sense of well being & decrease in score between 5-7.)

研究者

发起方
Rajkot Homoeopathic Medical College
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Megha Maheshkumar Vyas

Rajkot Homoeopathic Medical College, Parul University

研究点 (1)

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