DiarrheaNCT03005821
Chinese Pediatric Massage on Children With Acute Diarrhea: a Randomized Sham Massage Controlled Trial
A study of Diarrhea, run by Guangzhou University of Traditional Chinese Medicine at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy of Chinese pediatric massage as an add-on therapy while comparing with sham massage both on the basis of usual care for 0-6 years old children with acute diarrhea. Read more about this study
- Who is it for?
- Ages Up to 6 years
- Conditions the study is for
- Diarrhea
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- Jan 2017to 25 Oct 2019
- Phase
- Interventional
- 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 Up to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subject's symptoms meet the diagnosis criteria of acute diarrhea.
- The occurrence of diarrhea is no more than 72 hours.
- Stool frequency is equal or more than 5 times a day.
- Subject has not been involved in any other clinical trials at the same period of time.
- Subject's guardian may coordinate during the clinical trial.
- Subject's guardian have signed the informed consent.
Who cannot join
- A history of experiencing Chinese pediatric massage on hands
- Subject has cholera or malaria
- Subject with the following conditions on the manipulating part: phlebitis，open wound，fracture，tissue damage
- Subject has the follow complications: severe dehydration，metabolic acidosis，disorders of consciousness, seizures or twitching, shock, azotemia
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the efficacy of Chinese pediatric massage as an add-on therapy while comparing with sham massage both on the basis of usual care for 0-6 years old children with acute diarrhea.
Read the detailed description
Chinese pediatric massage has been practised as an option for the treatment of pediatric diarrhea for hundreds of years (since Ming Dynasty). The history of Chinese pediatric massage for health promotion is much longer, it can be traced back to more than one thousand years ago (652 AD). Many of the acupoints adopted in Chinese pediatric massage are unique if it is compared with those for adult massage. The manipulation is found to be easily accepted by children, as the strength of massage is gentle and soft. No severe adverse reaction in regards of Chinese pediatric massage was reported, the mild adverse reaction such as skin abrasion can be completely avoided with correct operating instructions.
- Conditions
- Diarrhea
- Being tested
- Chinese pediatric massage therapy + usual care, Sham massage therapy + usual care
- Keywords
- pediatric massage, Tuina therapy, acute diarrhea
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese pediatric massage therapy + usual careOther
Sham massage therapy + usual careOther
| Study group | Role | What they receive |
|---|---|---|
| pediatric massage | Experimental | Patients will receive Montmorillonite Powder and racecadotril granules as usual care according to different age or weight. Intravenous infusion, Oral Rehydration Salts (ORS), Zn,and antibiotics will be used if the pediatrician in charge considers necessary. Patients will receive Chinese pediatric massage once per day and for three days continuously. A cloak which can cover the child's hands and upper body will be required to put on, all the manipulations will be done under the cloak. Six acupoints will be adopted,i.e. Neibagua, Dachang,Xiaochang, Banmen, Fu, Tuishang Qijiegu. Each visit, children who are under 2 years old will receive manipulations on Neibagua for 500 times, 300 times for the other 5 acupoints each; if they are from 2-3 years old, the manipulations on Neibagua will be 700 times and 500 times for the other 5 acupoints respectively; while the manipulations on Neibagua will be 1000 times, and 800 times for the other 5 acupoints if the children are from 4-6 years old. Receives: Other: Chinese pediatric massage therapy + usual care |
| sham massage | Sham comparator | Patients will receive the same usual care as the experimental group. For the sham massage, the therapist will use one hand to hold the childrens' hand or just put one hand on childrens' body and the other hand will do the manipulations on the therapist's own hand instead childrens' hand or childrens' body. Patients will be required to put on the same kind of cloak as that for the the experimental group, all the manipulations will be done under the cloak. The manipulation times for each acupoints will be the same as those for experimental group in accordance with different age. The sham massage will be given once per day for 3 days continuously. Receives: Other: Sham massage therapy + usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diarrhea days
Measured: Within 14 days, the period of days from baseline to the first day that the diarrhea time reduces to equal to or less than 2 times per day.
The diarrhea times
The baseline and the 1st day of intervention are on the same day.
Measured: On the 3rd day.
Secondary outcomes (3)
Global change rating
much better，slightly better，unchanged，slightly worse，much worse
Measured: On the 7th day and 14th day from baseline (the baseline and the 1st day of intervention are on the same day).
Period of days when the stool character turns to normal
Measured: Within 14 days, the period of days from baseline to the first day that the stool character turns to normal.
Incidence of Treatment-Emergent Adverse Events
monitor adverse events
Measured: Within 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2016 (estimated)
- Study startJan 2017
- Primary completion25 Oct 2019
- Study completion25 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Dongguan Kanghua Hospital
- Responsible party
- Principal investigator, Darong Wu, Guangzhou University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03005821
- Sponsor's protocol ID
- 2013B032500014
- Status last verified
- Oct 2019
- First submitted
- 25 Dec 2016
- Last updated
- 29 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Lu T, Yin L, Chen R, Zhang H, Cai J, Li M, Dai L, Zhu C, Zhang Y, Xiang F, Wang L, Li L, Wang L, Wu D. Chinese pediatric Tuina on children with acute diarrhea: a randomized sham-controlled trial. Health Qual Life Outcomes. 2021 Jan 6;19(1):4. doi: 10.1186/s12955-020-01636-1.
PubMed 33407547Lu T, Zhang H, Yin L, Cai J, Li M, Dai L, Zhu C, Zhang Y, Xiang F, Wang L, Li L, Wang L, Wu D. Chinese pediatric Tuina on children with acute diarrhea: study protocol for a randomized sham-controlled trial. Trials. 2019 Dec 9;20(1):689. doi: 10.1186/s13063-019-3818-1.
PubMed 31815655
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chinese Pediatric Massage on Children With Acute Diarrhea: a Randomized Sham Massage Controlled Trial
- ClinicalTrials.gov ID
- NCT03005821
- Acronym / sponsor ID
- 2013B032500014
- Conditions
- Diarrhea
- Keywords
- pediatric massage, Tuina therapy, acute diarrhea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Guangzhou University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Dongguan Kanghua Hospital
- Study start
- Jan 2017
- Primary completion
- 25 Oct 2019 (actual)
- Study completion
- 25 Oct 2019 (actual)
- First posted
- 29 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy of Chinese pediatric massage as an add-on therapy while comparing with sham massage both on the basis of usual care for 0-6 years old children with acute diarrhea.
Detailed description
Chinese pediatric massage has been practised as an option for the treatment of pediatric diarrhea for hundreds of years (since Ming Dynasty). The history of Chinese pediatric massage for health promotion is much longer, it can be traced back to more than one thousand years ago (652 AD). Many of the acupoints adopted in Chinese pediatric massage are unique if it is compared with those for adult massage. The manipulation is found to be easily accepted by children, as the strength of massage is gentle and soft. No severe adverse reaction in regards of Chinese pediatric massage was reported, the mild adverse reaction such as skin abrasion can be completely avoided with correct operating instructions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pediatric massage | Experimental | Other: Chinese pediatric massage therapy + usual carePatients will receive Montmorillonite Powder and racecadotril granules as usual care according to different age or weight. Intravenous infusion, Oral Rehydration Salts (ORS), Zn,and antibiotics will be used if the pediatrician in charge considers necessary. Patients will receive Chinese pediatric massage once per day and for three days continuously. A cloak which can cover the child's hands and upper body will be required to put on, all the manipulations will be done under the cloak. Six acupoints will be adopted,i.e. Neibagua, Dachang,Xiaochang, Banmen, Fu, Tuishang Qijiegu. Each visit, children who are under 2 years old will receive manipulations on Neibagua for 500 times, 300 times for the other 5 acupoints each; if they are from 2-3 years old, the manipulations on Neibagua will be 700 times and 500 times for the other 5 acupoints respectively; while the manipulations on Neibagua will be 1000 times, and 800 times for the other 5 acupoints if the children are from 4-6 years old. |
| sham massage | Sham comparator | Other: Sham massage therapy + usual carePatients will receive the same usual care as the experimental group. For the sham massage, the therapist will use one hand to hold the childrens' hand or just put one hand on childrens' body and the other hand will do the manipulations on the therapist's own hand instead childrens' hand or childrens' body. Patients will be required to put on the same kind of cloak as that for the the experimental group, all the manipulations will be done under the cloak. The manipulation times for each acupoints will be the same as those for experimental group in accordance with different age. The sham massage will be given once per day for 3 days continuously. |
Who may qualify
- Ages
- Up to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Subject's symptoms meet the diagnosis criteria of acute diarrhea.
- The occurrence of diarrhea is no more than 72 hours.
- Stool frequency is equal or more than 5 times a day.
- Subject has not been involved in any other clinical trials at the same period of time.
- Subject's guardian may coordinate during the clinical trial.
Key exclusion criteria (4 listed)
- A history of experiencing Chinese pediatric massage on hands
- Subject has cholera or malaria
- Subject with the following conditions on the manipulating part: phlebitis，open wound，fracture，tissue damage
- Subject has the follow complications: severe dehydration，metabolic acidosis，disorders of consciousness, seizures or twitching, shock, azotemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chinese pediatric massage therapy + usual care | Other | pediatric massage |
| Sham massage therapy + usual care | Other | sham massage |
Primary outcome
Diarrhea days
Time frame: Within 14 days, the period of days from baseline to the first day that the diarrhea time reduces to equal to or less than 2 times per day.
The diarrhea times
Time frame: On the 3rd day.
The baseline and the 1st day of intervention are on the same day.
3 secondary outcomes
Global change rating
Time frame: On the 7th day and 14th day from baseline (the baseline and the 1st day of intervention are on the same day).
Period of days when the stool character turns to normal
Time frame: Within 14 days, the period of days from baseline to the first day that the stool character turns to normal.
Incidence of Treatment-Emergent Adverse Events
Time frame: Within 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2019.
- Derived from this study: PubMed 33407547Lu T, Yin L, Chen R, Zhang H, Cai J, Li M, Dai L, Zhu C, Zhang Y, Xiang F, Wang L, Li L, Wang L, Wu D. Chinese pediatric Tuina on children with acute diarrhea: a randomized sham-controlled trial. Health Qual Life Outcomes. 2021 Jan 6;19(1):4. doi: 10.1186/s12955-020-01636-1.
- Derived from this study: PubMed 31815655Lu T, Zhang H, Yin L, Cai J, Li M, Dai L, Zhu C, Zhang Y, Xiang F, Wang L, Li L, Wang L, Wu D. Chinese pediatric Tuina on children with acute diarrhea: study protocol for a randomized sham-controlled trial. Trials. 2019 Dec 9;20(1):689. doi: 10.1186/s13063-019-3818-1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Diarrhea, run by Guangzhou University of Traditional Chinese Medicine 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 6 inclusion and 4 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 29 Oct 2019. 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.
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?
Diarrhea days (time frame: Within 14 days, the period of days from baseline to the first day that the diarrhea time reduces to equal to or less than 2 times per day.). The study lists 2 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 NCT03005821, which also lists 2 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 29 Oct 2019.