The clinical research of cell-broken decoction pieces of sijunzi decoction in the treatment of Spleen-qi deficiency syndrome

As compared with traditional decoction pieces of sijunzi decoction, methods a multicenter, randomized, single-blind, parallel design, to evaluate the safety and efficacy of different dose of cell-broken decoction pieces of sijunzi decoction in treatment of Spleen-qi deficiency syndrome

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1800014725

Enrollment

Unknown

Registered

2018-01-31

Start date

2018-03-01

Completion date

Unknown

Last updated

2018-02-05

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

Conditions

Spleen-qi deficiency syndrome

Interventions

Traditional Chinese Medicine decoction pieces group:traditional decoction pieces of sijunzi decoction

isodose cell-broken decoction pieces group:cell-broken decoction pieces of sijunzi decoction

1/3 dose of cell-broken decoction pieces group:cell-broken decoction pieces of sijunzi decoction

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Aged 18 to 75 years old, including the 18 and 75 years old patients; (2) Fulfill the TCM diagnosed of Spleen-qi deficiency syndrome; (3) Patients who sign the informed consent form freely and voluntarily.

Exclusion criteria

Exclusion criteria: (1) Patients who have digestive system malignancies,or other serious digestive diseases; (2) Combined with severity serious disease, for example, the liver function (ALT,AST) exceeding 1.5 times than normal limit, the kidney function (Cr) exceeding the normal limit; (3) Participating in other clinical trial, or participated in any other clinical treatment within 30 days prior to screening; (4) Lactating or pregnant women,planning for pregnancy; (5) The researchers consider the patients are not suitable.

Design outcomes

Primary

Measure	Time frame
TCM syndrome;	—

Secondary

Measure	Time frame
the disappearingrate of symptomsandsigns;QOL;	—

Countries

China

Contacts

Public ContactSuiping Huang

Guangdong Provincial Hosptial of Chinese Medicine

gzdoctorhsp@126.com+86 13711026653

Outcome results

None listed

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