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NCT00130741
A Phase I, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group Study to Evaluate the Safety and Efficacy of a Combination Herbal Therapy (CHT), Versus Placebo in Improving the Overall Quality of Life and Symptoms in Patients With Irritable Bowel Syndrome (IBS)
Phase 1 trial testing CHT - herbal therapy in Colonic Diseases, Functional in 100 participants. Completed in 1 January 2007.
Quick facts
| Lead sponsor | Hadassah Medical Organization |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 1 July 2005 |
| Estimated completion | 1 January 2007 |
| Sites | 1 location across Israel |
Drugs / interventions tested
- CHT - herbal therapy — full drug profile →
Conditions studied
- Colonic Diseases, Functional — all drugs for Colonic Diseases, Functional →
Sponsor
Hadassah Medical Organization — full company profile →
Who can join
Adults 18 to 70, any sex, with Colonic Diseases, Functional. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
- To evaluate whether CHT administered orally (PO) induces a change in the overall QOL score from baseline values at 4 weeks of treatment measured via the IBS 36 questionnaire in patients with irritable bowel syndrome, relative to placebo
Sponsor's own description
This is an 8-week double-blind, placebo-controlled, randomized, parallel-group study with an additional two week baseline observation period to evaluate the safety of combination herbal therapy (CHT) versus placebo and short and long-term efficacy in terms of improved IBS, overall quality of life (QOL) and symptomatology.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00130741
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Colonic Diseases, Functional
Currently open trials in the same condition.
- NCT06271538 — Evaluation of Efficacy of Skål Pro Powder on Symptoms of Irritable Bowel Syndrome · Phase 4 · recruiting
- NCT05551052 — CRC Detection Reliable Assessment With Blood · active not recruiting
Other Hadassah Medical Organization trials
Trials by the same sponsor.
- NCT07430358 — Obstetric Risk Assessment & Cesarean-delivery in Labor Estimation Using Artificial Intelligence · NA · not yet recruiting
- NCT07429019 — Intraoperative Bupivacaine Injection to Reduce Acute and Chronic Pain After TVT/TVT-O Surgery. Randomized Double-Blind T · NA · not yet recruiting
- NCT07393568 — The Influence of Patient Use of Artificial Intelligence on Doctor-Patient Interaction and Clinical Outcomes in Endometri · not yet recruiting
- NCT07333430 — Study of Naive HBI0101 CAR-T Therapy in Relapsed/Refractory Multiple Myeloma · Phase 1 · recruiting
- NCT06762730 — Zoledronic Acid for the Prevention of TDF-sparing ART-induced Bone Mass Density Loss in Treatment-naive HIV Positive Ind · Phase 4 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00130741 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hadassah Medical Organization
- Last refreshed: 10 April 2007
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00130741.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing