To Prevent Scar Formation for Patients Underwent SurgeryEarly Phase 1NCT05017467
The Effect of Centella Asiatica Cream on Scar Tenderness Who Underwent Open Carpal Tunnel Release Surgery
A Early Phase 1 study testing undefinedCentella Asiatica Extract in people with To Prevent Scar Formation for Patients Underwent Surgery, run by Mustafa Balevi,MD at 2 sites in Turkey (Türkiye).
Trial summary
The centella asiatica cream applied to the wrist after the CTR surgery was found to be beneficial in preventing the scar tenderness in the thenar and hypothenar regions of the hand. Read more about this study
- Who is it for?
- Ages 19 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- To Prevent Scar Formation for Patients Underwent Surgery
- What is being tested?
- undefinedCentella Asiatica Extract
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Jan 2011to 1 Apr 2020
- 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 19 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria: patient underwent open carpal tunnel release surgery -
Exclusion Criteria:before hand surgery and recurrent carpal tunnel release surgery.
-
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Mustafa Balevi,MD
Konya, Meram, 42090
Study site
Konya
About this study
Official title: The Effect of Centella Asiatica Cream on Scar Tenderness in Patients Who Underwent Open Carpal Tunnel Release Surgery
The centella asiatica cream applied to the wrist after the CTR surgery was found to be beneficial in preventing the scar tenderness in the thenar and hypothenar regions of the hand.
Read the detailed description
Aim: This study was performed to evaluate the efficacy of centella asiatica extract in a cream preparation for the prevention of scar tenderness formation in patients who underwent conventional open carpal tunnel release surgery.
- Being tested
- undefinedCentella Asiatica Extract
- Keywords
- carpal tunnel syndrome, centella asiatica, surgery, cosmetic outcome, wound healing
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
undefinedCentella Asiatica ExtractDrug
Also called centella asiatica extract
All patients were asked about scar hypertrophy, scar tenderness, and pillar pain.
The scar assessment was performed using the Vancouver Scar Scale (VSS) at the one, three and 6 months after surgery.
Patients were asked to complete pre- and postoperative functional evaluations. The VAS score and QuickDASH test was used
| Study group | Role | What they receive |
|---|---|---|
| vss | Experimental | Vancouver Scar Scale (VSS) at the one, three and 6 months after surgery Receives: Drug: undefinedCentella Asiatica Extract |
| QuickDASH , VAS | Experimental | , Quick Disabilities of Arm Shoulder and Hand functional score (QuickDASH) and Visual Analogue Scale (VAS) test was used to determine overall hand function, activities of daily living, work performance, pain, aesthetics, and satisfaction with hand function Receives: Drug: undefinedCentella Asiatica Extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
centella asiatica extrate
treatment
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2021
- Study start1 Jan 2011
- Primary completion5 Jan 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Prevent Scar Formation for Patients Underwent SurgeryStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 280 operated patient with carpal tunnel release surgery.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mustafa Balevi,MD
- Sponsor type
- Other government
- Collaborators
- Konya Numune Hospital
- Responsible party
- Sponsor-investigator, Mustafa Balevi,MD, Konya Numune Hospital
- Investigators
- Ali Balevi, Principal investigator, İstanbul Medipol Üniversity,Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05017467
- Sponsor's protocol ID
- B.10.4.ISM.4.42.00.14-8271
- Status last verified
- Aug 2021
- First submitted
- 10 Apr 2021
- Last updated
- 23 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Centella Asiatica Cream on Scar Tenderness in Patients Who Underwent Open Carpal Tunnel Release Surgery
- ClinicalTrials.gov ID
- NCT05017467
- Acronym / sponsor ID
- B.10.4.ISM.4.42.00.14-8271
- Keywords
- carpal tunnel syndrome, centella asiatica, surgery, cosmetic outcome, wound healing
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Mustafa Balevi,MDOther government
- Collaborators
- Konya Numune Hospital
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 5 Jan 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 23 Aug 2021 (actual)
- 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 centella asiatica cream applied to the wrist after the CTR surgery was found to be beneficial in preventing the scar tenderness in the thenar and hypothenar regions of the hand.
Detailed description
Aim: This study was performed to evaluate the efficacy of centella asiatica extract in a cream preparation for the prevention of scar tenderness formation in patients who underwent conventional open carpal tunnel release surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 280 operated patient with carpal tunnel release surgery.
| Arm | Type | Receives |
|---|---|---|
| vss | Experimental | Drug: undefinedCentella Asiatica ExtractVancouver Scar Scale (VSS) at the one, three and 6 months after surgery |
| QuickDASH , VAS | Experimental | Drug: undefinedCentella Asiatica Extract, Quick Disabilities of Arm Shoulder and Hand functional score (QuickDASH) and Visual Analogue Scale (VAS) test was used to determine overall hand function, activities of daily living, work performance, pain, aesthetics, and satisfaction with hand function |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| undefinedCentella Asiatica ExtractAlso: centella asiatica extractAll patients were asked about scar hypertrophy, scar tenderness, and pillar pain. The scar assessment was performed using the Vancouver Scar Scale (VSS) at the one, three and 6 months after surgery. Patients were asked to complete pre- and postoperative functional evaluations. The VAS score and QuickDASH test was used | Drug | QuickDASH , VAS, vss |
Primary outcome
centella asiatica extrate
Time frame: 10 years
treatment
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 23 Aug 2021.
- Individual participant dataSharing planned: No
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.
Ali Balevi principal investigator
İstanbul Medipol Üniversity,Medical School
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing undefinedCentella Asiatica Extract in people with To Prevent Scar Formation for Patients Underwent Surgery, run by Mustafa Balevi,MD at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 23 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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. 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?
centella asiatica extrate (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Aug 2021; AzTrials last refreshed its copy on 7 Nov 2026.