跳至主要内容
临床试验/CTRI/2025/01/079570
CTRI/2025/01/079570尚未招募3 期

A single blind randomized comparative clinical trial to evaluate the efficacy of Panchkola Arka and Chaturbeeja Arka in the management of Udavartini Yonivyapad (Primary Dysmenorrhea)

DR SHIVANI SHARDA1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年2月5日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
80 % reduction in scoring of WALIDD

研究概览

简要总结

Primary Dysmenorrhea is the most common gynaecological problem that faced by women during their adolescence and is a common problem of the females in the reproductive age group. It is the spasmodic pain that confined to the lower abdomen and may radiate to the back and medial aspects of thighs without any pelvic pathology. Primary dysmenorrhea can be correlated with Udavartini Yonivyapad of Acharya Charaka or Udavarta of Acharya Sushruta.This trial is to evaluate and compare the efficacy of Panchkola Arka and Chaturbeeja Arka in the management of Udavartini Yonivyapad (Primary Dysmenorrhea). The trial will be performed in two groups one will be given Panchkola Arka and second will be given Chaturbeeja Arka .To avoid biasness investigator will be blinded in the study hence it a single blind study. Both the arka will be given in 10ml bd dose from 5 days prior to mensturation till 2nd day of periods. The observation and result will be analysed statistically with relevant tests and level of significance will be reported .Primary outcome will be - Reduction in scoring of WALIDD,80 % of reduction (Baseline and 3rd menstrual cycle) and secondary expected outcome will be: Reduction in associated symptoms i.e.  nausea, vomiting, headache etc.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 30.00 Year(s)(—)
性别
Female

入选标准

  • Subjects fulfilling the diagnostic criteria Subjects of Age group 18 to 30 years Married and unmarried women Subjects with regular menstrual cycles with the interval of 24 to 38 days History of painful menstruation for atleast 3 consecutive cycles Subjects without any structural pelvic pathology.

排除标准

  • Subjects experiencing menstrual pain attributed to underlying pelvic pathology diagnosed by USG like uterine fibroids adenomyosis endometriosis etc Subjects with Intrauterine contraceptive devices IUCDs Subjects with uncontrolled diabetes hypothyroidism and hypertension Subjects with a history of undiagnosed irregular vaginal bleeding Subjects who habitually consume analgesics antispasmodics sedatives or muscle relaxants within 48 hours before expected menstrual periods Subjects on Progesterone or Estrogen Pills Subjects with any structural pelvic pathology.

结局指标

主要结局

80 % reduction in scoring of WALIDD

时间窗: from 0th to 90th day

次要结局

  • Reduction in associated symptoms(from 0th to 90th day)

研究者

发起方
DR SHIVANI SHARDA
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

DR SHIVANI SHARDA

Shri dhanwantry ayurvedic college and hospital

研究点 (1)

Loading locations...

相似试验