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临床试验/CTRI/2023/11/060284
CTRI/2023/11/060284尚未招募2 期

PHASE II NON RANDOMIZED OPEN CLINICAL EVALUATION OF SIDDHA MEDICINE SATHIKKAI PODI FOR THE MANAGEMENT OF PITHA PERUMBADU (MENORRHAGIA)

V.ANITHA1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年12月4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
40
试验地点
1
主要终点
Reduced amount of Menstrual blood flow is

研究概览

简要总结

HMB or menorrhagia is the most common complaint among AUB.It is generally caused by conditions affecting the uterus or its vascularity, rather than disturbances in Hypothalamic - Pituitary - Ovarian (H-P-O) axis. Symptoms of HMB may

include, bleeding through one or more pads or tampons every one or two hours, passing blood clots larger than the size of quarters, bleeding that often lasts longer than eight days, Inability to perform regular daily activities because of the

bleeding. Menorrhagia affects up to 30% of women in their reproductive period. Over 5% of women ages between 30-49 years consult gynaecologist each year with this complaint. Thus, in Siddha system of Medicine, there are unique combination

of medicines, which have solution to the present scenario of excessive or prolonged menstrual bleeding. One such combination is SATHIKKAI PODI which will be cost effective and reliable.

The aim of the study is the management of PITHA PERUMBADU (MENORRHAGIA) with siddha medicine SATHIKKAI PODI and the objective is to determine the therapeutic efficacy and safety profile of the

siddha medicine SATHIKKAI PODI in the management of PITHA PERUMBADU (MENORRHAGIA).

As the literary evidences support the usage of medicine, in the disease, hypothesis is created such a way that the efficacy of SATHIKKAI PODI will be a better solution for PITHA PERUMBADU (MENORRHAGIA).

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
15.00 Year(s) 至 50.00 Year(s)(—)
性别
Female

入选标准

  • Excessive menstruation (Bleeding.
  • one or more pads or tampons every 2 hours) Prolonged menstruation (Bleeding.
  • lasts longer than eight days)Puberty menstruation Premenopausal menorrhagia Menorrhagia in PCOD Hb level above 8gms.

排除标准

  • Fibroid polyp Bleeding disorders Hypothyroidism Abortion and pregnancy Ovarian feminizing tumour Adenomyosis Chocolate cyst Uterine fibroids Endometrial cancer Uterine sarcomas.

结局指标

主要结局

Reduced amount of Menstrual blood flow is

时间窗: 3 weeks

assessed by number of sanitary pads used

时间窗: 3 weeks

before and after treatment by the chart

时间窗: 3 weeks

PICTORIAL BLOOD ASSESSMENT CHARTS

时间窗: 3 weeks

(PBAC)

时间窗: 3 weeks

次要结局

  • Improvement in Hb will be monitored(Improvement of Hb will be monitored in the)

研究者

发起方
V.ANITHA
申办方类型
Other [Government Siddha Medical College]
责任方
Principal Investigator
主要研究者

Dr V ANITHA

Govt. Siddha medical college, chennai

研究点 (1)

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