Clinical Study of Premenstrual Syndrome and its Management with Unani Drug Revand chini
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
- Safety and efficacy of unani single drug in the management of Premenstrual syndrome
研究概览
简要总结
The etiology of Premenstrual syndrome is complicated, and according to the hypothesized causes, various conventional therapeutic approaches have been recommended. As it is a chronic condition that needs prolong treatment for three to six months, therefore special attention should be paid to the side effects of pharmacological interventions.
Various drugs used in this condition are benzodiazepines, selective serotonin reuptake inhibitors and gonadotropin releasing hormone (GnRH) agonists. Despite a fair success rate of these medicines, each has a substantial adverse effect profile such as dysphoria, insomnia, muscle cramps, nausea, perspiration and tremor.
Therefore, the need of the hour is to switch towards complementary and alternative treatment for premenstrual syndrome. Which would be safe, less costly, more effective, easily available, and efficacious for the management of premenstrual syndrome.
In Unani classical texts, various plant products may be useful to treat symptoms of Premenstrual syndrome such as Qust Shireen, Sumbul-ul-Teeb, Asl-us-Soos, Tukhm-e-Sambhalu, Pudina, Bisfayej and Revand chini.
Several drugs have been subjected for clinical evaluation in Premenstrual syndrome such as Tukhm e Sambhalu, Balchar, Bisfayej and Pudina.
Revand Chini contains a number of phenolic compounds including anthroquinones, stilbenes, tannin, polysaccharides and others which are proved to have various type of associated pharmacological activity. Ibn Sina in The Canon of Medicine and Ibn Baitar in Compendium on Simple Medicaments and Foods given description for its usefulness in PMS .
According to a previous clinical study Revand chini has proved to be effective in primary dysmenorrhea but its effect on symptoms of follicular phase (Premenstrual phase) is not documented yet.
Therefore, in view of above, Revand chini (Rheum emodi) is selected to conduct clinical trial to evaluate it’s efficacy in the management of premenstrual syndrome.
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
- 14.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Patient aged within the range of 14 to 45 years, irrespective of marital status and parity.
- •2.Patient having regular spontaneous menstrual cycle of 21 to 35 days presenting with signs and symptoms of premenstrual syndrome for at least 3 menstrual cycles as per ACOG guidelines.
- •3.Patients who are able to understand and willing to report for follow ups and to sign the consent form.
排除标准
- •1.Patients presenting with irregular menstrual cycle.
- •2.Patient on oral contraceptive pills and lactating women.
- •3.Patient having history of any unstable medical illness and seizure disorder.
- •4.Diagnosed case of personality disorder, depression or anxiety.
- •5.Patients with any systemic illness like renal or liver diseases.
- •6.Alcohol abuse or any other substance abusers.
结局指标
主要结局
Safety and efficacy of unani single drug in the management of Premenstrual syndrome
时间窗: 3 months or 3 menstrual cycles
次要结局
- Effect of unani drug in the improvement of quality of life of patient suffering from premenstrual syndrome.(3 months)
研究者
Dr Bisma
Ayurvedic and Unani Tibbia College and Hospital