An Open Labelled Single Arm Clinical Study To evaluate the Efficacy and safety of Grace Hing (Hing oil 15mg) HPMC Capsules in the Treatment of Primary Dysmenorrhea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- NUTRA GRACE
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- treatment(Grace hing capsule-15mg). Each
研究概览
简要总结
Grace Hing oil capsules are 100% Vegan & natural supplement. Grace Hing oil capsules serves as perfect natural remedy for abdominal bloating and gas problems. It activates secretion of more digestive enzymes and promotes healthy digestion with no loss of nutrition. Hing or Asafoetida is rich in antioxidants and may provide multiple benefits, particularly for digestive health.
Benefits of using Grace Hing Capsules
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Grace Hing oil capsules being rich in fiber aids digestion and gas problems.
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Grace Hing oil capsules may help lower blood pressure by relaxing blood vessels.
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Hing oil has anti-inflammatory and antioxidant properties.
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Provides Relief from Respiratory Problems
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Provides relief with uterine spasm and abdominal spasm
Suggested dosage:
2 Capsules a day or as directed by Health care practioner.
Direction: As a dietary supplement, Keep out of reach of childrean
Each HMPC Capsules contains: Hing Oil- 15 mg
Ingredients:
other ingredients: Frankincense Oil, Coconut oil, Vitamin-E. Banding solution: HPMC, IPA,
Chocolate Brown Colour and water.
storage: Below 25c in a cool, dry and dark place.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Healthy female patients between 18 – 35 years of age.
- •2.Patient has a history of Over-the-Counter (OTC) analgesic use for treatment of primary dysmenorrhea; 3.Patient has a history of regular menstrual cycles that typically occurs between every 21 to 35 days 4.Patients having a self-reported history of primary dysmenorrhea with other causes of dysmenorrhea having been excluded.
- •5.Patient who normally experiences pain relief from the analgesic medications in taken.
排除标准
- •1.Patient has a known allergy to any of the excipients in any of the study medication products.
- •GI Disorders hepatic, renal, neurologic, cardiovascular, psychiatric, endocrine, respiratory, surgical procedure.
- •3.Patient has an ongoing sexually transmitted disease or has abnormal vaginal discharge.
- •4.Patient has a current or past history of severe gastritis, gastrointestinal bleeding or ulceration.
- •Patient has a current or past history of one or more of the following conditions: secondary dysmenorrhea, pelvic inflammatory disease, urinary tract infection, adnexal masses, uterine fibroids, endometriosis, adenomyosis that in the opinion of the Investigator would impact patient safety and/or the study data.
- •patient requires prescription Analgesics, narcotic, non-NSAID or has routinely taken OTC medications in excess of label recommended instructions for control of dysmenorrhea symptoms.
结局指标
主要结局
treatment(Grace hing capsule-15mg). Each
时间窗: 3 days before the beginning of the menstrual | period and up to three days after termination of | the menstrual period.
treatment use on the VAS scale from 0 to 100,
时间窗: 3 days before the beginning of the menstrual | period and up to three days after termination of | the menstrual period.
where 0 determines- "No pain" and 100
时间窗: 3 days before the beginning of the menstrual | period and up to three days after termination of | the menstrual period.
determines "Very painful". Then, the difference
时间窗: 3 days before the beginning of the menstrual | period and up to three days after termination of | the menstrual period.
between the two measurements will be
时间窗: 3 days before the beginning of the menstrual | period and up to three days after termination of | the menstrual period.
participant will rank the severity of her
时间窗: 3 days before the beginning of the menstrual | period and up to three days after termination of | the menstrual period.
dysmenorrhea symptoms before and after the
时间窗: 3 days before the beginning of the menstrual | period and up to three days after termination of | the menstrual period.
The difference between the reported Visual
时间窗: 3 days before the beginning of the menstrual | period and up to three days after termination of | the menstrual period.
Analogue Scale before and after the
时间窗: 3 days before the beginning of the menstrual | period and up to three days after termination of | the menstrual period.
calculated
时间窗: 3 days before the beginning of the menstrual | period and up to three days after termination of | the menstrual period.
次要结局
- To assess the improvement in the quality of life(determined by SF- 36 health survey)
- To assess the associated systemic symptoms(Score of Dysmenorrhea)
- To assess the PBLAC score for menstrual blood(loss.)