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临床试验/CTRI/2025/12/098749
CTRI/2025/12/098749尚未招募2 期

Efficacy of Joshanda Baboona and its Sitz Bath in Usr al Tamth Tashanuji Spasmodic Dysmenorrhea A Randomized Standard Controlled Study

Government Unani Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2025年12月20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
46
试验地点
1
主要终点
Change in VAS score

研究概览

简要总结

Usr al Tamth Dysmenorrhea means difficult menstruation but the term is commonly used to refer to painful menstruation. Many women with dysmenorrhea experience additional menstrual related symptoms such as backache ,headache diarrhea, nausea and vomiting. The first 24 to 48 hours after the start of menstrual flow, or within a few hours before or after, are usually characterized by these symptoms. Dysmenorrhea affects 16.8percent to 81percent of women, according to the WHO, with prevalence estimates among women and adolescents ranging from 25 percent to 90 percent Studies from India have shown prevalence rates ranging from 50 percent to 87.8 percent It affects more than half of females aged 18 to 25 years old. Dysmenorrhea is classified into two types: Primary dysmenorrhea, which describes cyclic menstrual pain without an identifiable associated pathology and Secondary dysmenorrhea, which frequently complicates conditions such as endometriosis, leiomyomas, PID, adenomyosis, endometrial polyps and menstrual outlet obstruction.

In conventional medicine, the treatment of choice for this problem generally includes NSAIDs, hormonal preparations like OCPs and surgery. However, these methods have also been found to have a failure rate of 20-25 percent. Additionally, these drugs can aggravate gastrointestinal problems and lead to adverse drug interactions.

Unani physicians have discussed dysmenorrhea and its management under the heading of Waja al Rahim, Dard al Rahim. Various single drugs such as Zanjabeel Zingiber officinale Roscoe. Saunf Foeniculum vulgare Mill, Zafran Crocus sativus L., Zeera Siyah Cuminum cyminum Linn. Baboona Matricaria chamomila L, Hulba Trigonella foenum-graecum L.and Shuneez Nigella sativus L have been proven for their efficacy. Baboona Matricaria chamomilla L has been selected for the treatment of dysmenorrhea in the present study as it possess properties such as Mudirr i Hayd emmenagogue, Mudirr-i-Bawl diuretic, Idrar al-Laban lactagogue, Muhallil e Awram anti inflammatory, Musakkin analgesic, Daf i Tashannuj antispasmodic and Mufatche Suddad 9-12 Hence, oral administration in the form of Joshanda Baboona Matricaria chamomilla L and its sitz bath have been chosen to validate its efficacy in Usr al Tamth Tashanuji.

Abzan is a method where the patient sits in a shallow tub filled with plain or medicated water, covering up to the umbilicus. It is commonly advised by Unani physicians for gynecological disorders such as menstrual disorders, genital prolapse, vaginal infections a pelvic inflammatory disease.

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
12.00 Year(s) 至 35.00 Year(s)(—)
性别
Female

入选标准

  • 1.Both unmarried and married participants with age group of 12 to 35years.
  • 2.Participants with regular painful menstruation associated with one or more symptoms like lower backache,nausea,vomiting,diarrhea and fatigue.
  • 3.Visual Analogue Scale VAS score for pain intensity more than 4.

排除标准

  • 1.Hb percent less than 7gms percent will be excluded.
  • 2.Participants with systemic illness like hypertension,diabetes mellitus,thyroid dysfunction.
  • 3.Participants with pelvic pathology like pelvic inflammatory disease,uterine fibroid, endometriosis,adenomyosis 4.Participants allergic to NSAIDs. 5.Participants on any hormonal treatment.
  • 6.Lactating women within 6 months.

结局指标

主要结局

Change in VAS score

时间窗: Before, every month for 3 months during the trial and one follow up in subsequent cycle

次要结局

  • 1.Change in SF 12 scale for QoL(2.Change in Verbal Multidimensional Scoring scale)

研究者

发起方
Government Unani Medical College and Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr. Summaiya Mulla

Government Unani Medical College And Hospital

研究点 (1)

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