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临床试验/CTRI/2022/05/042652
CTRI/2022/05/042652已完成不适用

An Open labelled, Single arm, clinical study to Evaluate Efficacy and Safety of GRACE HING (Hing oil 15 mg) HPMC Capsules in the Treatment of Abdominal Pain and Functional Dyspepsia

NUTRA GRACE1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2022年5月22日最近更新:

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
The primary outcome was a decrease in VAS for

研究概览

简要总结

Grace Hing oil capsules are 100% Vegan & natural supplement. Grace Hing oil capsules serves a 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

Grace Hing oil capsules being rich in fiber aids digestion and gas problems.

Grace Hing oil capsules may help lower blood pressure by relaxing blood vessels.

Hing oil has anti-inflammatory and antioxidant properties.

Provides Relief from Respiratory Problems

Provides relief with uterine spasm and abdominal spasm.

Suggested dosage:

2 Capsules a day or as directed by Health care practicioner.

Direction:

As a dietary supplement, Keep out of reach of children

Each HMPC Capsules contains: Hing Oil- 15 mg

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
Not Applicable
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Subjects of age group between 18-60 years are included in the study.
  • Subjects who are considered to healthy systemically without any comorbidities and malignancy are included in the study.
  • Subjects fulfilling the Rome Diagnostic criteria are included in the study.
  • Subjects with abdominal pain irrespective of underlying diagnosis related toGastro-Intestinal system are included in the study.
  • Subjects with complaints of frequent occurrences of abdominal pain due to natureof the disease are included in the study.
  • Subjects who are willing to give informed consent without any hindrance areincluded in the study.

排除标准

  • Subjects below 18 years and above 60 years of age are excluded from the study.
  • Subjects with complaints of abdominal spasms due to other systemic diagnosis apart from Gastro-Intestinal systems such as renal calculi, gall bladder stones, etc, are excluded from the study.
  • Subjects who are not willing to give informed consent are excluded from the study.
  • Subjects with co morbidities such as; Type 2 Diabetes mellitus, hypothyroidism, Hypertension are excluded from the study.
  • 5.Subjects who have been diagnosed of chronic diseases such as cardiovascular diseases, cancer, respiratory conditions, orthopaedic conditions associated with early and late complications are excluded from the study
  • Subjects who are associated with long tern usage of analgesics & who has pasthistory of Gastro-intestinal surgery are excluded from the study.
  • Subjects with persistent GI bleeding and frequent vomiting are excluded from the study.

结局指标

主要结局

The primary outcome was a decrease in VAS for

时间窗: day 0 and day 30

pain intensity.

时间窗: day 0 and day 30

次要结局

  • To assess the Nepean Dyspepsia Index (NDI)(Baseline , Day 1 to Day 30)
  • To assess Global overall symptom scale(Day 1 to Day 30)
  • To assess Adverse events(Day 1 to Day 30)
  • To assess Gastrointestinal Symptom Rating(Scale(GSRS))

研究者

发起方
NUTRA GRACE
申办方类型
Pharmaceutical industry-Indian

研究点 (1)

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