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The Randomized controlled trial of constipation No. 1 formula in treating functional constipation (syndrome of qi deficiency and fluid deficiency) in the elderly

The Randomized controlled trial of constipation No. 1 formula in treating functional constipation (syndrome of qi deficiency and fluid deficiency) in the elderly

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400081592
Enrollment
Unknown
Registered
2024-03-06
Start date
2024-03-15
Completion date
Unknown
Last updated
2024-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Constipation

Interventions

Test Group:To give constipation No. 1, specifications: 9G/Pill, 3 pills, once a day, morning or bedtime.The drug was given continuously for 6 weeks, with a lead-in period of one week before administra
Control group:Cistanche laxative oral liquid: Specification: 10ml/Stick, once a day, once a stick, in the morning or before going to bed.The drug was given continuously for 6 weeks, with a lead-in per

Sponsors

The second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) According to the Rome IV diagnostic criteria for functional constipation and constipation of deficiency of qi and fluid; (2) During the lead-in period (1 week) , less than 3 times of spontaneous defecation; (3) Aged 60 or above; (4) Volunteer to participate in the trial and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1)constipation caused by intestinal stricture caused by organic pathological changes of rectum and colon (such as tumor, inflammation, Crohn's disease, intestinal adhesion, colon polyp, colon tuberculosis, etc.) ; (2)constipation caused by Hirschsprung's disease (HD) , neurological disorders (e.g. autonomic neuropathy, cerebrovascular disease) , mental disorders, metabolic and endocrine disorders (e.g. hypothyroidism, diabetes) , muscular diseases (e.g. amyloidosis, dermatomyositis) , etc. (3)drug-related constipation, such as antidepressants, antiepileptic drugs, antihistamines, anticonvulsants, antipsychotic, antispasmodic drugs, calcium antagonists, diuretics, Monoamine oxidase inhibitor, opioids, Sympathomimetic drug, antacids containing aluminium or calcium, calcium, iron, antidiarrheals, non-steroidal anti-inflammatory drug, etc. (4)drug-related constipation, such as antidepressants, antiepileptic drugs, antihistamines, anticonvulsants, antipsychotic, antispasmodic drugs, calcium antagonists, diuretics, Monoamine oxidase inhibitor, opioids, Sympathomimetic drug, antacids containing aluminium or calcium, calcium, iron, antidiarrheals, non-steroidal anti-inflammatory drug, etc. (5)drug-related constipation, such as antidepressants, antiepileptic drugs, antihistamines, anticonvulsants, antipsychotic, antispasmodic drugs, calcium antagonists, diuretics, Monoamine oxidase inhibitor, opioids, Sympathomimetic drug, antacids containing aluminium or calcium, calcium, iron, antidiarrheals, non-steroidal anti-inflammatory drug, etc. (6)allergic to the components of this preparation; (7)patients with severe cardiovascular and cerebrovascular diseases (such as hypertension and coronary heart disease) , liver, kidney and hematopoietic system diseases (8)patients with anxiety, depression or tendency (9)pregnant or lactating women, (10) patients treated with laxative drugs in the last 2 weeks (11) patients who have participated in other clinical trials in the last 1 month (12)researchers consider it inappropriate to participate in clinical trials.

Design outcomes

Primary

MeasureTime frame
Defecation;Quantitative score;

Secondary

MeasureTime frame
Safety, including vital signs;

Countries

China

Contacts

Public ContactHuang Yuhong

The second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

hyh101@126.com+86 22 6063 7918

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026