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临床试验/CTRI/2025/02/081003
CTRI/2025/02/081003尚未招募2/3 期

Efficacy of Asarun versus Sumbul ul teeb in Premenstrual Syndrome- A randomised clinical study

National Institute of Unani Medicine1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2025年3月5日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
入组人数
64
试验地点
1
主要终点
Reduction in PMTS Score

研究概览

简要总结

The National Institute of Mental Health definition states that premenstrual changes or the cyclic occurrence of symptoms that are of sufficient severity to interfere with some aspects of life and which appear with consistent and predictable relationships to menses.PMS is characterized by a group of physical, emotional, and psychological symptoms of varying severity starting a week before the onset of menstruation and ends after the onset of menstruation**.Worldwide prevalence of PMS is about 80%-90%,and that in India ranges from 14.3%-74.4%.The aetiology of PMS is unclear hence, definitive treatment is not available. However, several possible treatments have been established based on symptomatic relief .Current treatment options for PMS, which include Selective Serotonin Reuptake Inhibitors (SSRIs) and hormonal therapy are limited, both in terms of their efficacy and associated side effects often only partially alleviating symptoms.It is estimated that up to 80% of the worlds population rely on herbal medicines as a primary source of healthcare and traditional medical practice and some of these medicinal plants have been shown to be effective in relieving PMS symptoms.The ancient physicians mentioned that, *ImtilÄikaifiat*exist in the premenstrual phase which leads to number of features like anxiety, headache, irritability, insomnia, decreased concentration, palpitations etc.It is well studied that surge of AkhlÄt­-i-Muharrika (hormones) are responsible for the accumulation of body fluid in tissue spaces during premenstrual phase and this theory correlates with the concept given by IbnSina and others.Several unani drugs like Mushktramashi, Sumbul-ut-teeb, Parsiyawashan, Asarun, Anisoon, Zanjabeel, Zafran, Baboona, Gouzaban, Asgandh, Methi, Qust etc which possess properties Muharrik-i-as**ab, Muqawwi-i-asab, Munaqi-i-asab, Muqawwi-i-dim**agh, Munaqi-i-dim**agh, Mudirr-i-bawl, Mudirr-i-haiz, Muqawwi-i-gurda, Muqawwi-i-mida, Mufatteh sudad, Muhallil-i-awarm, Mulattif, Musakkin, Muqawwi-i-jigar, Mulayyin-i-shikam, Qabid activitiesand are described to overcome the various symptoms associated with PMS**.**Of these Asarun  is selected to  evaluate its effect in comparison with Sumbul-ut-teeb in the management of PMS.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 35.00 Year(s)(—)
性别
Female

入选标准

  • Patients aged between 18 and 35 years.
  • Having a regular menstrual cycle with a cycle length of 21-35 days.
  • Presenting with symptoms of premenstrual syndrome (diagnosed by ACOG criteria).
  • Having a minimum PMTS score more than 17 and VAS score more than 4.

排除标准

  • Patients with any organic pelvic pathology,Use of hormonal therapy or oral contraceptives in past 3 months,A known systemic or metabolic disease (Thyroid disease, Diabetes mellitus, Hypertension).

结局指标

主要结局

Reduction in PMTS Score

时间窗: Follow up will be done monthly for 3 consecutive cycles during the trial and once after the completion of trial.

次要结局

  • Reduction in VAS Score(Follow up will be done monthly for 3 consecutive cycles during the trial and once after the completion of trial)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

DrNimra Irfan

National Institute of Unani Medicine

研究点 (1)

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