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临床试验/CTRI/2025/01/079184
CTRI/2025/01/079184尚未招募2 期

A Comparative Study on the Effect of Rasnadarvadi Kashaya Orally along with Trivrit Taila Anuvasana Basti and Saptasara Kashaya Orally along with Shatpushpa Taila Anuvasana Basti in Kashtartava with special reference to Primary Dysmenorrhoea

Faculty of Ayurveda Institute of Medical Sciences BHU1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年2月1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
50
试验地点
1
主要终点
Vibhandha (Constipation)

研究概览

简要总结

Primary dysmenorrhea is common complaint among reproductive age females. It is characterized by painful menses. Pain is spasmodic and confined to lower abdomen, may radiate to back and medial aspect of thighs associated with other physical and/or psychological symptoms. According to ayurveda all gynaecological disorders are caused by vitiation of vata dosha and they are described under Yoni vyapada. In present study an attempt made to correlate Primary Dysmenorrhea with Kashtartava (Udavartini /Vataja Yoni Vyapad) as mentioned in ayurvedic classics and to compare the effect of Rasnadarvadi Kashaya orally along with Trivrit Taila Anuvasana Basti and Saptasara Kashaya orally along with Shatpushpa Taila Anuvasana Basti in Primary dysmenorrhea.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

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

入选标准

  • Age group 16 -30 years.
  • Patients complaining of painful menstruation for at least 2 consecutive cycles.
  • Patients having regular menstrual cycle.
  • Patients who are ready for necessary investigations and agreed to come for follow up regularly.
  • Patients who are ready for the trial and ready to sign the informed consent.

排除标准

  • 1.Patient of age less than 16 and above the age of 30 years.
  • 2.Patients with any history of allergy 3.Pregnant women 4.Women with chronic ailments (systemic diseases like TB, DM, jaundice, bronchial asthma, cardiovascular diseases) 5.Patients having anorectal diseases.
  • 6.Patient having any history of psychological disorders.
  • 8.Patient having congenital anomalies leading to dysmenorrhoea.
  • 9.Patient having pelvic inflammatory disease and any pelvic pathology .
  • 10.Patient taking any hormonal therapy and IUCD.

结局指标

主要结局

Vibhandha (Constipation)

时间窗: 4 follow up with equal interval of 30 days

Based on assessment criteria 1.Pain in lower abdomen, low back or medial aspect of thighs during menses (VAS scale and WaLIDD score).

时间窗: 4 follow up with equal interval of 30 days

2.Duration of pain

时间窗: 4 follow up with equal interval of 30 days

3.Characteristic of menstrual blood

时间窗: 4 follow up with equal interval of 30 days

Amount of bleeding

时间窗: 4 follow up with equal interval of 30 days

4.Clinical features like Praseka/Chhardi (Nausea/Vomiting)

时间窗: 4 follow up with equal interval of 30 days

Bhrama (Vertigo)

时间窗: 4 follow up with equal interval of 30 days

Atisara (Diarrhoea)

时间窗: 4 follow up with equal interval of 30 days

Shirhshoola (Headache)

时间窗: 4 follow up with equal interval of 30 days

次要结局

  • Reduced Pain and associated symptoms(4 follow ups with Regular interval of 30 days.3 follow ups with medication and 1 follow up without medication)

研究者

发起方
Faculty of Ayurveda Institute of Medical Sciences BHU
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Sujata Admane

Banaras Hindu University

研究点 (1)

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