Laxative Effectiveness of a Phytotherapeutic Tea

Status Completed

Clinical Trial Summary

The aim of this study is to evaluate the efficacy and safety of a phytotherapeutic laxative tea, composed by Pimpinella anisum, Foeniculum vulgare, Sambucus nigra and Cassia angustifolia, in a randomized crossover placebo-controlled clinical trial in patients with chronic constipation.

Clinical Trial Description

The Klein Laxative Tea is a pharmaceutical phytotherapeutic product that's been used for several years in Brazil for the treatment of constipation. This product contains fruit of Pimpinella anisum (green anises), fruit of Foeniculum vulgare (fennel), flowers of Sambucus nigra (elder tree) and flowers of Cassia angustifolia (senna). In spite of the beneficial effects of its components, separately demonstrated in vitro, it never had its effectiveness appraised in a randomized clinical trial.The purpose of this study was to evaluate the efficacy and safety of this product in a randomized crossover placebo-controlled clinical trial. Twenty patients presenting with the criteria of the American Association of Gastroenterology for chronic constipation were included, and concluded a two-phase crossover study. The primary endpoint was the evaluation of the intestinal transit time measured through radiological technique. The secondary endpoints were the number of evacuations, subjective impression of the quality in the intestinal habit, quality of life appraised through WHOQOL-brief and adverse effects. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00872430
Study type	Interventional
Source	Hospital de Clinicas de Porto Alegre
Contact
Status	Completed
Phase	Phase 2
Start date	July 2002
Completion date	June 2003

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05980988` - Effectiveness and Safety of Probiotic in Regulating Chronic Constipation	N/A
Recruiting	`NCT03819062` - Sacral Neuromodulation as Treatment for Chronic Constipation	N/A
Completed	`NCT00765882` - Phase III, Randomized, Double-Blind, Placebo-Controlled, Trial of Linaclotide Administered to Patients With Chronic Constipation	Phase 3
Completed	`NCT00730171` - An Open-label, Long-term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation	Phase 3
Completed	`NCT00354575` - Effect of Chinese Herb on Chronic Constipation for Residents in Long-Term Care Units	Phase 2
Active, not recruiting	`NCT03119584` - Efficacy of Linaclotide in Type II Diabetics With Chronic Constipation	Phase 4
Completed	`NCT00765999` - An Open-Label, Long-Term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation	Phase 3
Completed	`NCT01793753` - Effect of Propofol on Internal Anal Sphincter Pressure During ARM	N/A
Completed	`NCT00746200` - Acupuncture for Chronic Constipation	Phase 3
Enrolling by invitation	`NCT00671684` - Endoscopic Mucosal Resection (EMR) for Diagnosis of Hirschsprung's Disease	Phase 1/Phase 2
Completed	`NCT00391820` - Evaluate the Safety and Efficacy of a 5-HT4 Agonist in Chronic Constipation (ACCORD Trial)	Phase 2
Completed	`NCT00404040` - Movicol in Childhood Constipation (ProMotion Study)	Phase 2
Completed	`NCT02281630` - Phase II Dose-Finding Study of KWA-0711 in Patients With Chronic Constipation (CC)	Phase 2
Completed	`NCT00256984` - Study of Stapled Transanal Rectal Resection (STARR) Surgery in Refractory Constipation Associated With Obstructive Defecation Syndrome (ODS)	Phase 4
Recruiting	`NCT05192317` - Administration of a Natural Molecular Complex in Functional Chronic Constipation	N/A
Active, not recruiting	`NCT05202028` - The Efficacy of Massage and Reflexology Applications in Children With Cerebral Palsy	N/A
Completed	`NCT05734859` - Drinking Effect of Electrolyzed Alkaline Reduced Water on Functional Constipation	N/A
Completed	`NCT01007123` - Study of A3309 in Patients With Chronic Idiopathic Constipation	Phase 2
Completed	`NCT00402337` - Dose-range-finding, Phase 2 Trial of Oral Linaclotide Acetate Administered to Patients With Chronic Constipation	Phase 2
Completed	`NCT02961556` - General Clinical Study of AJG555 in Pediatric Patients With Chronic Constipation	Phase 3