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ConstipationEarly Phase 1NCT03186079

Efficacy of Chinese Herbal Medicine Xiaojidaozhi Decoction in the Treatment of Childhood Constipation

A Early Phase 1 study testing Xiaojidaozhi Decoction, Fiberform and Toilet training in people with Constipation and Chinese Herbal Medicine, run by Shengjing Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Constipation is the most common complaint in childhood gastrointestinal disease,affecting an estimated 20% of the global children.The treatment strategies consist of diet control,behavioural intervention and oral and sometimes rectal laxatives. Read more about this study

Who is it for?
Ages 4 to 14 years
Conditions the study is for
Constipation, Chinese Herbal Medicine
What is being tested?
Xiaojidaozhi Decoction, Fiberform and Toilet training
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
200 participants
Where
1 siteChina
Study dates
1 May 2017to 1 May 2018
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 14 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Clinical diagnosis of childhood constipation
  • Criteria of constipation meets the Rome IV criteria(H3a)
  • Must be able to swallow capsules

Who cannot join

  • Digestive tract diseases
  • Neurologic diseases
  • Endocrine diseases
  • Metabolic diseases
  • Gastrointestinal surgery
  • Using drugs which can take impact on bowl motility

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shengjing Hospital

    Shenyang, Liaoning, 110004

Other trials in China

About this study

Official title: Efficacy of Chinese Herbal Medicine Xiaojidaozhi Decoction in the Treatment of Childhood Functional Constipation: a Double Blind, Randomized and Placebo-controlled Trial

Constipation is the most common complaint in childhood gastrointestinal disease,affecting an estimated 20% of the global children.The treatment strategies consist of diet control,behavioural intervention and oral and sometimes rectal laxatives. Given higher success rate and fewer side effects,the laxative PEG3350 has been considered the first choice in childhood constipation.However, effectiveness of PEG 3350 laxative is not lasting, additional treatment interventions are still necessary.With an unsatisfactory response to current treatments, many patients seek help from Chinese Herbal Medicine.In view of the traditional theory, childhood constipation is derived from weakness of gastric and splenic function.The functional weakness is characterized by food stagnation and further pathological heat accumulation in the gastrointestine. The food stagnation can slow the gastrointestinal motility while heat causes constipation by drying the intestines and their content. Therefore, the therapeutic principles and practices for childhood constipation must focus on the pathophysiological basis accordingly. In the documented traditional medicine dictionary(Pi Wei Lun), Xiaojidaozhi Decoction is well described in improving the gastric and splenic function, eliminating food stagnation and removing pathological heat accumulation, and it has always been used in treatment of constipation throughout Asia since the first description in Pi Wei Lun in 1249. It comprises twelve herbs. Through the combined action of these herbs, Xiaojidaozhi Decoction can increase fluid in the intestines and facilitate the gastrointestinal motility, relieving the symptoms of constipation. Despite of the long history of successful use of Xiaojidaozhi Decoction in childhood constipation, a large randomized placebo-controlled trial is still not available.The aim of this study was to explore the clinical efficacy and safety of Chinese herbal medicine Xiaojidaozhi Decoction in the treatment of childhood constipation.

Being tested
Xiaojidaozhi Decoction, Placebo, Fiberform, Toilet training
Medical subject headings
Constipation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Xiaojidaozhi DecoctionDrug

    Also called XJD

    Mixture of twelve Chinese herbal medicines granule

  • PlaceboDrug

    Also called Placebos

    Mixture of 10% Chinese herbal medicines granule and 90% artificial gum

  • FiberformDrug

    Fiberform is a low-phytate wheat fibre which can increase the gastrointestinal motility.

  • Toilet trainingBehavioural

    Toilet training has been considered a routine method in treatment of constipation

Study groups in NCT03186079
Study groupRoleWhat they receive
Xiaojidaozhi DecoctionActive comparatorXiaojidaozhi Decoction and Fiberform and Toilet training are used for treatment of childhood Constipation
Receives: Drug: Xiaojidaozhi Decoction; Drug: Fiberform; Behavioral: Toilet training
non-Xiaojidaozhi DecoctionPlacebo comparatorPlacebo and Fiberform and Toilet training are used for treatment of childhood Constipation
Receives: Drug: Placebo; Drug: Fiberform; Behavioral: Toilet training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of overall efficacy

    Efficacy is ranked as cured, improved, same/worse

    Measured: week 8(end of treatment)

  2. Percentage of overall efficacy

    Efficacy is ranked as cured, improved, same/worse

    Measured: week 20(end of follow-up)

  3. Baseline of constipation score in the beginning of treatment

    Constipation is evaluated and scored on the related symptoms of stool frequency, appearance,consistency and incontinence

    Measured: beginning of treatment(baseline)

  4. Change of constipation score from the baseline in the end of treatment

    Constipation is evaluated and scored on the related symptoms of stool frequency, appearance,consistency and incontinence

    Measured: week 8(end of treatment)

  5. Change of constipation score from the baseline in the end of follow-up

    Constipation is evaluated and scored on the related symptoms of stool frequency, appearance,consistency and incontinence

    Measured: week 20(end of follow-up)

Secondary outcomes (1)

  1. Incidence of Treatment-Emergent Adverse Events

    The adverse events reported in treatment

    Measured: Within week 20(end of follow-up)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2017
  2. Study start1 May 2017
  3. Primary completion1 May 2018
  4. Study completion1 May 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03186079
Sponsor's protocol ID
A333-2
Status last verified
Nov 2023
First submitted
4 Jun 2017
Last updated
22 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Voskuijl W, de Lorijn F, Verwijs W, Hogeman P, Heijmans J, Makel W, Taminiau J, Benninga M. PEG 3350 (Transipeg) versus lactulose in the treatment of childhood functional constipation: a double blind, randomised, controlled, multicentre trial. Gut. 2004 Nov;53(11):1590-4. doi: 10.1136/gut.2004.043620.

    PubMed 15479678

  • Tran LC, Di Palma JA. Lack of lasting effectiveness of PEG 3350 laxative treatment of constipation. J Clin Gastroenterol. 2005 Aug;39(7):600-2. doi: 10.1097/01.mcg.0000170769.67320.47.

    PubMed 16000928

  • Cheng CW, Bian ZX, Zhu LX, Wu JC, Sung JJ. Efficacy of a Chinese herbal proprietary medicine (Hemp Seed Pill) for functional constipation. Am J Gastroenterol. 2011 Jan;106(1):120-9. doi: 10.1038/ajg.2010.305. Epub 2010 Nov 2.

    PubMed 21045817

  • Qiao L, Wang LJ, Wang Y, Chen Y, Zhang HL, Zhang SC. A Randomized, Double-Blind, and Placebo-Controlled Trial of Chinese Herbal Medicine in the Treatment of Childhood Constipation. Clin Transl Gastroenterol. 2021 May 3;12(5):e00345. doi: 10.14309/ctg.0000000000000345.

    PubMed 33938874

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Xiaojidaozhi Decoction, Fiberform and Toilet training in people with Constipation and Chinese Herbal Medicine, run by Shengjing Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of overall efficacy (time frame: week 8(end of treatment)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03186079, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.

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