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临床试验/CTRI/2025/01/079187
CTRI/2025/01/079187尚未招募不适用

Randamized Controlled Clinical Trial To Evaluate The Role Of Varshabhubilwadi Kashaya In Kashtartava With Special Reference To Primary Dysmenorrhea

Matoshree Asarabai Darade College Babhulgoan ,Yeola1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年1月30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
80
试验地点
1
主要终点
1)Lower Abdominal pain

研究概览

简要总结

Dysmenorrhea is the most common gynecological problem faced by women during their adolescence resulting in physical discomfort and anxiety. In Ayurveda, Kashtartava is not described as a separate disease entity but there are many other diseases which can be correlated with Kashtartava like Vataja Yonivyapada, Udavarta Yonivyapada, Vataja Aartavadushti, etc.

According to modern science, Dysmenorrhea is painful menstruation of sufficient magnitude so as to incapacitate day-to-day- activities. The primary dysmenorrhea is the one where there is no identifiable pelvic pathology. The incidence of primary dysmenorrhea of sufficient magnitude pathology with incapacitation is about 15- 20%. Non-steroidal anti-inflammatory drugs (NSAID’s) are the main pharmacological treatments.

Dysmenorrhea is commonly reported menstrual disorder which affects the working ability and quality of life of women, which further affects community as well in terms of school and work absenteeism of females. Dysmenorrhea is a symptom complex with involvement of physical, psychological, emotional symptoms mainly affecting young females in the world, hampering their domestic, academic, social and professional pursuits.

The prevalence of a dysmenorrhea estimates ranges from 25-95% among women and adolescent.Prevalence of dysmenorrhea reported from the studies in India is 84.20% .

PURPOSE OF SELECTION OF TOPIC-

Most of the previous research works include treatment of Dysmenorrhea with  administration of Basti karma. Not all patients can invest required time, money and efforts for the procedure, so there is need to develop oral medication for the same. Use of NSAIDs for dysmenorrhea is more popular among younger age group as it provides faster relief and is easily available OTC,so there is need of time to develop Ayurvedic formulations which will be easy to administer, have no side effects and reduce the use of NSAIDs.

The Varshabhubilwadi Kashaya is Vata Kapha Prashamaka, Rakta PrasadakaVibandhagna, Vatanulomaka properties. It regulates Apana vayu so as to improve the functions of organs in Apan kshetra.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 25.00 Year(s)(—)
性别
Female

入选标准

  • 1.Patients willing to participate in the study.
  • 2.Patients having classical signs and symptoms of Kashtartava.
  • 3.Females of age group 18-25 years.
  • 4.Painful menstruation for at least 3 consecutive cycles.
  • 5.Regular menstruation cycle ranging from 21 days to 35 days with normal bleeding 3-7 days.
  • 6.Patients who have not taken any medication for dysmenorrhea like OC pills for last 3 months.

排除标准

  • 1.Severe anemic patient with Hb less than 7 gm per dl 2.Abdominal pain associated with excessive bleeding PV, Endometriosis, PID, Fibroids, ovarian cyst like pelvic pathology.
  • 3.Patients having any systemic illness i.e., known case of Hypertension, Diabetes Mellites, Hyperthyroidism, Hypothyroidism, Renal disorders, Hepatic disorders, sexually transmitted diseases, appendicitis.
  • 4.Hysteric Patients.
  • 5.Patient having congenital anomaly or structural anomaly.
  • 6.Patient with Intrauterine contraceptive device.

结局指标

主要结局

1)Lower Abdominal pain

时间窗: First day of first menstrual cycle,first day of second menstrual cycle,first day of third menstrual cycle,first day of fourth menstrual cycle

2)Lower backache

时间窗: First day of first menstrual cycle,first day of second menstrual cycle,first day of third menstrual cycle,first day of fourth menstrual cycle

3)Headache

时间窗: First day of first menstrual cycle,first day of second menstrual cycle,first day of third menstrual cycle,first day of fourth menstrual cycle

4)Nausea

时间窗: First day of first menstrual cycle,first day of second menstrual cycle,first day of third menstrual cycle,first day of fourth menstrual cycle

5)Vomiting

时间窗: First day of first menstrual cycle,first day of second menstrual cycle,first day of third menstrual cycle,first day of fourth menstrual cycle

6)Constipation

时间窗: First day of first menstrual cycle,first day of second menstrual cycle,first day of third menstrual cycle,first day of fourth menstrual cycle

all above symptoms will be decreased.

时间窗: First day of first menstrual cycle,first day of second menstrual cycle,first day of third menstrual cycle,first day of fourth menstrual cycle

次要结局

  • Above mentioned symptoms decreased.(First day of first menstrual cycle,first day of second menstrual cycle,first day of third menstrual cycle,first day of fourth menstrual cycle)

研究者

发起方
Matoshree Asarabai Darade College Babhulgoan ,Yeola
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Jagruti Jagannath More

Matoshree Asarabai Darade Ayurved College Babhulgoan ,Yeola

研究点 (1)

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