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临床试验/CTRI/2025/08/092232
CTRI/2025/08/092232尚未招募2 期

RANDOMISED CONTROLLED CLINICAL TRIAL TO STUDY THE EFFECT OF NAGARADI GUTIKA IN THE MANAGEMENT OF UDAVARTINI YONIVYAPAD W.S.R TO PRIMARY DYSMENORRHOEA

Dr Rajgauri Appasaheb Mengawade1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年8月12日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
To determine the efficacy of Nagaradi Gutika in Udavartini Yonivyapad with special reference to Primary Dysmenorrhea

研究概览

简要总结

This is Randomized open controlled clinical study to evaluate the efficacy of Nagaradi Gutika in the management of painful menstruation  that will be conducted in OPD of Matoshree Asarabai Darade Ayurveda Mahavidyalaya Bhabulgaon. The primary outcome measures will be to assess the effect of drug after 5days and 4 weeks and secondary outcomes will be measured after 3 menstrual cycles during treatment and after 1 month after the treatment is completed.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

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

入选标准

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

排除标准

  • The following individuals will be excluded from the study:
  • Patients with any systemic illness, including: Hypertension Diabetes Mellitus Hyperthyroidism or Hypothyroidism Renal disorders Hepatic (liver) disorders Sexually transmitted diseases Appendicitis 2.Patients exhibiting hysterical behavior or diagnosed with hysteria.
  • 3.Patients with congenital anomalies or structural abnormalities.
  • 4.Patients with severe anemia (Hemoglobin level < 7 gm%).
  • 5.Patients experiencing abdominal pain associated with: Excessive vaginal bleeding Endometriosis Pelvic Inflammatory Disease (PID) Uterine fibroids Ovarian cysts or similar pelvic pathologies 6.Patients currently using intrauterine contraceptive devices (IUCDs).

结局指标

主要结局

To determine the efficacy of Nagaradi Gutika in Udavartini Yonivyapad with special reference to Primary Dysmenorrhea

时间窗: 1 weeks ,4 weeks, | 4months

次要结局

  • 1.To compare the efficacy of Nagaradi Gutika and Noble Spas in Udavartini Yonivyapad, with special reference to Primary Dysmenorrhea.

研究者

发起方
Dr Rajgauri Appasaheb Mengawade
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Rajgauri Appasaheb Mengawade

Matoshree Asarabai Darade Ayurveda Mahavidyalaya

研究点 (1)

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