Clinical Trial on Palliative Cancer Patients With Constipation

Watumiaji waliosajiliwa tu ndio wanaweza kutafsiri nakala

Ingia / Ingia

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HaliImekamilika

Wadhamini

Hong Kong Baptist University

Washirika

Caritas Medical Centre, Hong Kong

Yan Chai Hospital

Our Lady of Maryknoll Hospital

Hong Kong Buddhist Hospital

Hospital Authority, Hong Kong

JARIBIO LA KLINIKI: NCT02795390

BioSeek: NCT02795390

Maneno muhimu

Kikemikali

It is a double-blinded, randomized, placebo-controlled trial for advanced cancer patients with constipation. 60 patients will be randomly assigned to have individualized herbal intervention (treatment group) or placebo (control group) in 1:1 ratio. For the treatment group, MaZiRenWan 10g plus HuangQi 20g are chosen as the core prescription. Furthermore, six herbal granules can be added according to the syndrome differentiated for individual participant. Placebo is made from dextrin (76.03%), tea essence (23.61%), gardenin (0.02%), and caramel (0.34%) to achieve color, smell, taste, and texture comparable to the herbal granules. Patients are instructed to dissolve the granules in 150ml of hot water, twice daily for two weeks. The primary end point is the global symptom improvement. Secondary outcome measures include stool frequency, stool form, use of rescue herbal granules, constipation visual analogue scale (CVAS) (0=none to 7=most severe) and individual assessment of constipation related symptoms. For the safety profiles of herbal intervention, the important adverse events reported and clinical laboratory evaluations of liver and renal function are determined.

Tarehe

Imethibitishwa Mwisho:	07/31/2018
Iliyowasilishwa Kwanza:	05/24/2016
Uandikishaji uliokadiriwa Uliwasilishwa:	06/05/2016
Iliyotumwa Kwanza:	06/09/2016
Sasisho la Mwisho Liliwasilishwa:	08/05/2018
Sasisho la Mwisho Lilichapishwa:	08/07/2018
Tarehe halisi ya kuanza kwa masomo:	10/31/2016
Tarehe ya Kukamilisha Msingi iliyokadiriwa:	07/31/2018
Tarehe ya Kukamilisha Utafiti:	07/31/2018

Hali au ugonjwa

Constipation

Uingiliaji / matibabu

Drug: Chinese herbal medicine

Drug: Placebo

Awamu

Awamu 2

Vikundi vya Arm

Mkono	Uingiliaji / matibabu
Experimental: Chinese herbal medicine MaZiRenWan 10g plus HuangQi 20g are chosen as the core prescription. Furthermore, six herbal granules can be added according to the syndrome differentiated for individual participant. They are ShuDiHuang 15g and Danggui 10g for deficiency of blood, Maidong 15g and ShengDiHuang 10g for deficiency of Yin, and RouCongRong 15g and Niuxi 10g for deficiency of Yang.	Drug: Chinese herbal medicine
Placebo Comparator: Placebo Placebo is made from dextrin (76.03%), tea essence (23.61%), gardenin (0.02%), and caramel (0.34%) to achieve color, smell, taste, and texture comparable to the herbal granules.	Drug: Placebo

Mkono

Uingiliaji / matibabu

Experimental: Chinese herbal medicine

MaZiRenWan 10g plus HuangQi 20g are chosen as the core prescription. Furthermore, six herbal granules can be added according to the syndrome differentiated for individual participant. They are ShuDiHuang 15g and Danggui 10g for deficiency of blood, Maidong 15g and ShengDiHuang 10g for deficiency of Yin, and RouCongRong 15g and Niuxi 10g for deficiency of Yang.

Drug: Chinese herbal medicine

Placebo Comparator: Placebo

Placebo is made from dextrin (76.03%), tea essence (23.61%), gardenin (0.02%), and caramel (0.34%) to achieve color, smell, taste, and texture comparable to the herbal granules.

Drug: Placebo

Vigezo vya Kustahiki

Zama zinazostahiki Kujifunza	18 Years Kwa 18 Years
Jinsia Inastahiki Kujifunza	All
Hupokea Wajitolea wa Afya	Ndio
Vigezo	Inclusion Criteria: - Severity of constipation > 3 points (an 8-point scale from 0 to 7) - Palliative Performance Scale ≥60% - Relatively stable liver and renal function within 3 months - Patients who can read and speak Chinese Exclusion Criteria: - Inability to communicate - Presence of a colostomy, or gastrointestinal obstruction - Presence of loose or watery stool (Bristol stool scale 6-7) or bowel movement > 3/day under routine laxative treatment - History of Chinese herbal medicine allergies - Estimated life expectancy less than 1 month

Matokeo

Hatua za Matokeo ya Msingi

1. Global symptom improvement (improved / same / worse) [2 weeks]

Participants are asked to rate their impression of change in constipation symptoms in comparison with their baseline, with scores from 0 to 6 represents markedly worse or better at the respective extremes. The response categories are collapsed to simply "improved" for score 4-6, "same" for score 3, or "worse" for score 0-2.

Hatua za Matokeo ya Sekondari

1. Number of bowel movement (times/day) [2 weeks]

2. Stool form [2 weeks]

Stool form is assessed with 7-point Bristol Stool Scale (ranging from "separate hard lumps" to "watery")

3. Extra laxatives used (times/week) [2 week]

4. Constipation visual analogue scale [2 weeks]

The severity of constipation is evaluated by an eight point ordinal rating scale (0=none to 7=most severe)

5. Constipation related symptoms [2 weeks]

Sensation of straining, incomplete evacuation, bloating, abdominal pain/cramping, nausea, and passing of gas are recorded using a 7-point ordinal scale (0=not at all and 6=very severe)

6. Adverse events [2 weeks]

7. Blood creatinine level (umol/L) [2 weeks]

8. Blood urea level (mmol/L) [2 weeks]

9. Serum glutamic pyruvic transaminase(SGPT) Level (U/L) [2 weeks]

10. Serum Glutamic Oxaloacetic Transaminase (SGOT) Level (U/L) [2 weeks]

Clinical Trial on Palliative Cancer Patients With Constipation

Maneno muhimu

saratani

constipation

dextrin

gardenin

Kikemikali

Tarehe

Hali au ugonjwa

Uingiliaji / matibabu

Awamu

Vikundi vya Arm

Vigezo vya Kustahiki

Matokeo

Hifadhidata kamili ya mimea ya dawa inayoungwa mkono na sayansi