跳至主要内容
临床试验/CTRI/2022/07/044092
CTRI/2022/07/044092尚未招募2 期

A randomised controlled trial to evaluate the efficacy of Hinguwadi gutika and Rajahpravartini vati in the Management of Udavarta Yonivyapad W.S.R. to Primary Dysmenorrhea.

NATIONAL INSTITUTE OF AYURVEDA1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年11月25日最近更新:

试验速览

阶段
2 期
状态
尚未招募
入组人数
30
试验地点
1
主要终点
1. NRS – Scale: Numeric Rating Scale for Dysmenorrhoea

研究概览

简要总结

Menstruation is normal vaginal bleeding that happens as part of woman’s monthly menstrual cycle. Dysmenorrhea is the condition of painful menstrual periods or menstrual discharge associated with pain. It is seen commonly in teenage girls and in young women. Dysmenorrhea is seen with mild to moderate intensity, and in up to 20% of women it may be severe enough to interfere with daily activities. The pain is most often manifests as menstrual cramps, like a throbbing pain or cramping pain in lower abdomen. It may also be associated with low-back pain, pain in thighs, leg pains, nausea, vomiting, diarrhea etc. It is commonly divided into primary dysmenorrhea and secondary dysmenorrhea. In Primary dysmenorrhoea pain occurs without any organic pathology and initial onset takes place usually 6-12 months after menarche, when ovulatory cycles are established. Pain duration is commonly 8 to 72 hours and is usually associated with the onset of menstrual flow.

NULL HYPOTHESIS [H0]

There is no difference in Oral administrationof Hinguvadi gutikaandRajahpravartani vati in managing the Udavarta Yonivyapadwith special reference to Primary dysmenorrhea.

ALTERNATIVE  HYPOTHESIS [H1]

There is difference between in Hinguvadi gutika and        Rajahpravartavi vati in managing the Udavarta Yonivyapadwith special reference to Primary dysmenorrhea.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

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

入选标准

  • PATIENTS WITH CHIEF COMPLAINT OF PAIN DURING MENSES ALONG WITH ASSOCIATED SYMPTOMS.
  • PATIENTS WHO HAVE MENSTRUAL PAIN SCORE MORE THAN GRADE I ACCORDING TO VERBAL MULTIDIMENSIONAL SCORING SYSTEM (VMSS).
  • PATIENTS WHO HAD REGULAR MENSTRAL CYCLES OF 23-35 DAYS IN THE LAST 3 MONTHS.
  • PATIENT IN AGE GROUP OF 18 TO 30 YEARS
  • PATIENTS WITH H/O USING ANALGESICS DURING MENSES.
  • PATIENT WILLING TO GIVE VOLUNTARY INFORMED CONSENT FOR THE STUDY.

排除标准

  • The patient suffering from any severe systemic, or autoimmune disorders, specially those who are mentioned as Asadhya vyadhi as per clinical text of Ayurveda will be excluded.
  • Subjects having organic pathology of uterus and adnexa like Fibroid uterus,carcinoma of endometrium, endometriosis etc.
  • 1having pelvic inflammatory disease or 2chronic leucorrhoea.
  • 3Patients who vaccinated for covid19 with in past three month.

结局指标

主要结局

1. NRS – Scale: Numeric Rating Scale for Dysmenorrhoea

时间窗: 60 DAYS

次要结局

  • 1. VMSS scale: Verbal Multidimensional Scoring System(60 DAYS)

研究者

申办方类型
Other [GOVERNMENT AYURVEDA COLLEGE]

研究点 (1)

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