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Completed

NCT Number: NCT01418066

Ayurvedic Herbs in Diarrhea Predominant Irritable Bowel Syndrome

In the present study the investigators are trying to evaluate the effect of Murraya koenigii leaves, Punica granatum and Curcuma which is administered to the patients in a combined form as tea. This study will help to evaluate the effect of these preparations scientifically in improving the IBS symptoms.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinik für Naturheilkunde und Integrative Medizin

Essen, North Rhine-Westphalia, 45276, Germany

About this study

see above

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Irritable Bowel Syndrome according to Rom-III
  • Subtype Diarrhea or Alternating
  • discomfort or pain > 1 times a week
  • discomfort or pain > 4 on a Visual Analog Scale

Exclusion criteria

  • Inflammatory bowel diseases (test results necessary)
  • Lactose, Fructose Malabsorption (test results necessary)
  • Celiac Disease
  • Pregnancy or Breastfeeding
  • Colectomy or Hemicolectomy >50cm
  • Severe metabolic disorders, hormonal disorders, cardiac or respiratory failure, liver or renal diseases
  • severe depression, psychotic or psychiatric disorders, substance abuse
  • cancer within the last 5 years
  • allergy to caraway
  • acute inflammatory diseases

Treatment and study plan

Ayurvedic Herbs

Drug

A tea made of Murraya koenigii leaves, Punica granatum and Curcuma as powder. Decoction of 12ml powder in 100ml hot water is taken twice daily at least 30 minutes before a meal.

Placebo tea

Drug

Graminis Flores and Maidis stigmata as a powder. Decoction made of 12ml in 100ml hot water. To drink twice daily at least 30 Minutes before a meal.

Primary outcomes

  1. irritable bowel syndrome- symptom severity score

    Time frame: T2 (Day 28)

    IBS-SSS(Francis, 1997)

Secondary outcomes

  1. Frequency of abdominal discomfort/Pain

    Time frame: last week of treatment (days 21-28)

    Diary, daily rating of pain

  2. Intensity of Abdominal Pain/Discomfort

    Time frame: Last week of treatment (days 21-28)

    Diary, daily rating of pain on a 100mm Visual Analog Scale

  3. Stool and diarrhea Frequency

    Time frame: last week of treatment (days 21-28)

    Diary, daily counts

  4. Quality of life

    Time frame: T2 (Day 28)

    measured with the EQ-5D

  5. IBS Specific Quality of life

    Time frame: T2 (Day 28)

    measured with the IBS-QOL (Patrick, 1998)

  6. Depression and Anxiety

    Time frame: T2 (day 28)

    HADS questionnaire (Hermann, 1995)

  7. Adequate Relief Score

    Time frame: at day 7, 14, 21 and 28

    Adequate Relief Score (Mangel, 1998)

  8. Global improvement

    Time frame: at days 7, 14, 21 and 28

    Question on global improvement: How have your symptomes changed compared to the last week: from much worse to much better on a 7-point scale

  9. adverse events

    Time frame: up to week 15

    all adverse events

Sponsors and collaborators

Lead sponsor

Universität Duisburg-Essen

Other

Registry information

Official study title

Feasibility and Safety of Ayurvedic Herbs in Diarrhoea-predominant Irritable Bowel Syndrome

Acronym: AHIB

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 16, 2011
Registry last updated
Dec 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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