ERASNCT07087366
Enhanced Recovery After Surgery(ERAS) Following Gynaecological Oncology Surgery in a Tertiary Level Hospital
A study testing ERAS protocol in people with ERAS and Cancer, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
Trial summary
Enhanced recovery after surgery (ERAS) protocols are multimodal perioperative care pathways designed to achieve early recovery after surgical procedures by maintaining preoperative organ function and reducing the profound stress response following surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- What is being tested?
- ERAS protocol
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Jun 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between the age of 18-70 years,
- diagnosed case with cervical, uterine or ovarian cancer,
- Admitted for surgical management .
Who cannot join
- Patients with severe comorbidity, including DM,CRD,CLD
- patients with American Society of Anesthesiologists risk ≥ 4,
- severe organ dysfunction or failure.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bangladesh1 site, 1 recruiting
- Recruiting
Jannat Ferdous
Dhaka, 1000
JANNAT FERDOUS, 01711607919
About this study
Official title: Enhanced Recovery After Surgery(ERAS) Pathway Following Gynecological Oncology Surgery in a Tertiary Level Hospital:A Prospective Randomized Controlled Trial
Enhanced recovery after surgery (ERAS) protocols are multimodal perioperative care pathways designed to achieve early recovery after surgical procedures by maintaining preoperative organ function and reducing the profound stress response following surgery.
The principle of ERAS is to optimize the patient's health before surgery, minimize stress to the body, and restore function to normal rapidly by taking steps before, during, and after surgery, to decrease the length of stay in the hospital, reduce recovery time, prevent complications, readmissions, same day discharge (SDD) and patient's satisfaction.
Read more
The aim of this study is to introduce the ERAS recommendations into the management of gynaecological surgical procedures in compared to conventional procedures.
After taking permission from Institutional Review Board (IRB) of BSMMU, the proposed study will be started. After taking informed written consent and matching eligibility criteria, a total 160 patients will be selected in this prospective randomized control study. This study will be conducted in the Department of gynecological oncology, BSMMU for two years from April 2024 to March 2026. There will be two group in this study, patients of Group A will be selected for ERAS protocol from preoperative to postoperative event up to follow up. Patients of Group B will be selected for conventional method. Outcome of both procedure in terms of hospital stay, costs, requirement of analgesia and complications will be compared. Statistical analyses of the results will be obtained by using window-based computer software devised with Statistical Packages for Social Sciences (SPSS-25).
Read the detailed description
Over 234 million major surgical procedures are performed globally each year and despite advances in surgical and anaesthetic care, morbidity after abdominal surgery is still high. Fasttrack or enhanced recovery after surgery (ERAS) clinical pathways have been proposed to improve the quality of perioperative care with the aim of attenuating the loss of functional capacity and accelerating the recovery process.
The ERAS pathways reduce the delay until full recovery after major abdominal surgery by attenuating surgical stress and maintaining postoperative physiological functions. The implementation of the ERAS pathways has been shown to impact positively in reducing postoperative morbidity, and as a consequence, length of stay in hospital.
The concept of ERAS was first published by Engelman and colleagues in cardiac surgery in 1994. Subsequently, ERAS Society was formed in the early 2000s by a group of European surgeons (ERAS Society guidelines was formed). Early studies were primarily focused on colorectal surgery, and in 2003 (Marx and colleagues) this concept was demonstrated in gynecologic oncology. The first ERAS guidelines in gynecologic oncology were published in 2016. Updated guidelines for ERAS in gynecologic oncology were published in 2019.
Components of ERAS are preoperative, intraoperative and post operative. Pre-operative component includes: Patient education regarding the surgery and the expected post-operative course, ensuring the patient is as healthy as possible prior to surgery through exercise \& weight loss, optimal pre-operative fasting guidelines that will allow solid food until 6 hours pre-operatively and intake of clear fluids until 2 hours prior to surgery. A Cochrane review reported that preoperative carbohydrate treatment was associated with reduced post-operative insulin resistance, enhanced return of bowel function, and shorter hospital stay with no effect on post-operative complication rates, length of hospital stay (LOSH) and its related costs. In recent years, several studies have highlighted the impact of the anaesthetic management on postoperative morbidity and mortality.
In view of the evidence that many elements of the ERAS programme published by the ERAS Society in 2009 are of related to anaesthetic care, it is imperative that guidelines on perioperative care include recommendations approved by an interdisciplinary team comprising anaesthesiologists and surgeons.
Most of the ERAS elements have been already discussed extensively, specifically for different types of surgical procedures, as well the quality of evidence supporting each ERAS element. It must be acknowledged that evidence supporting some of the ERAS elements still remains controversial. The historical significance of ERAS has been established since 1990 (REF) in general surgery, orthopaedics and urology. ERAS resulted in increased patient satisfaction, shorter hospital stays, reduced postoperative complications and reduced treatment costs, which contribute to increased hospital productivity.
There are a number of reports in the literature on the implementation of the ERAS programme into the care of gynaecological patients . Minimally invasive surgery is advisable in ERAS protocol in order to reduce surgical complications, wound infections, incidence of deep vein thrombosis and hospital stay.
There is a strong opinion that the majority of gynaecological procedures can be done without mechanical bowel preparation (enema) .
One of the demonstrated advantages of restricting the administration of intravenous fluids to surgical patients is the reduction of pulmonary complications . Another recommendation is the avoidance of opioids, which can cause nausea, vomiting and ileus .
Regarding Health Economics Benefits; Direct medical and indirect non-medical costs were significantly lower in the ERAS group, there was a significant reduction in total hospital stay, intravenous fluid use, complications and duration of epidural use in the ERAS group, The implementation of an ERAS program causes overall cost-saving of roughly $6900 per patient.
The aim of this study is to introduce the ERAS recommendations into the management of gynaecological procedures in our institution.
Rationale of the research:
Optimization of care in the perioperative period is increasingly being recognized as a means of improving outcomes after surgery. This began with the concept of enhanced recovery after surgery (ERAS) which described pre, intra, and post-operative factors to improve patient outcomes after surgery.
Following recommendations are advocated for preoperative preparation while doing major gynaecological oncological surgery: No preoperative mechanical bowel preparation as several studies have shown that oral antibiotics alone compared with no bowel preparation significantly reduced post-operative infectious morbidity including anastomotic leaks. ERAS protocol also recommend that all gynecologic oncology patients who undergo major surgery > 30 min should receive dual VTE mechanical prophylaxis and chemoprophylaxis. Perioperative prophylaxis should begin before the induction of anesthesia Intra-operative component includes use of multimodal and opioid-sparing analgesia, targeting perioperative goal-directed fluid therapy that reduces length of stay \& complications in high-risk patients undergoing abdominal surgery . Minimally invasive surgery remains an important tenet of ERAS and is recommended for appropriate patients when long-term oncologic outcomes are similar, where expertise and resources are available .
Post-operative component includes adequate pain control, early mobilization, early oral intake. A regular diet within the first 24 hours after gynecologic/oncology surgery is recommended, High protein diets may be considered, multi-disciplinary post-operative patient follow-up is required. Patient Reported Outcomes, including functional recovery and audit also one of the most important component of ERAS protocol that allow institutions to monitor, understand, and compare functional recovery in a patient-centered fashion.
But the conventional protocol that has been practicing for our patients so far is complicated as it involves preoperative mechanical bowl preparation that stats 3 days prior to surgery, preoperative and post operative use of opioids and more analgesics.
So, the conventional protocol causes more length of hospital stay, patients discomfort and less turn over that ultimately increase hospital cost for the patients.
There are limited study done to evaluate the optimization of ERAS protocol in Bangladesh and no study was performed so far in gynaecological cancer surgery. This study is done to determine the ultimate outcome of gynaecological oncology surgery following ERAS protocol and compare it with the conventional method in BSMMU .
Hypothesis:
The perioperative and post operative in patients undergoing gynaecological cancer surgeries following ERAS protocol is better than that of the conventional method.
Objective:
General objective:
To find out the perioperative and postoperative outcome in patients undergoing gynaecological cancer surgeries following ERAS protocol (Group A) compared with conventional method(Group B).
Specific objectives:
- To compare the perioperative pain score, day of first flatus, any complications in patients undergoing gynaecological cancer surgeries following ERAS protocol and in patients following conventional protocol.
- To compare the costs , hospital stay, complications, readmission rate, reoperation rate, postoperative mortality in both the groups.
- Being tested
- ERAS protocol
- Keywords
- RCT
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERAS protocolProcedure or surgery
Procedure: ERAS protocol
| Study group | Role | What they receive |
|---|---|---|
| ERAS group | Experimental | Preoperative:
* Education
* No bowel preparation
* Fasting up to 6 h before surgery
* Oral carbohydrate solution (50 G in 200 mL water, 2 hours before surgery
Day of surgery:
* Insertion of Foley catheter
* Antiembolic stockings
* Fluid restriction (4-5 L)
* 0.2% Bupivacaine during incision closure
* Sip of water 2 hours later after surgery
* Postoperative LMWH injection
* Antiembolic stockings
* Foley removal as early as possible
* Drain removal as early as possible
* Ambulation at morning \& continue and encourage ambulation
* Fluid restriction (1-2 L
* NSAIDs/ Paracetamol bid for 3 days for analgesia IV PCA (Epidural)
* Semifluid diet in POD1
* Soft blended diet in POD2 Receives: Procedure: ERAS protocol |
| Conventional Group | No intervention | Before and after Surgery: * Bowel preparation * Midnight fasting * Insertion of Foley catheter * Antiembolic stockings * Fluid (5-6L) * Fluid (2L-3L) * Semifluid diet after first flatus Post-operative: * Use of Narcotic analgesia * Prolonged immobilization * NPO till bowel sound * Prolonged catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
hospital stay
duration of hospital stay in ERAS group
Measured: 3 to 4 days
Secondary outcomes (7)
Day of first flatus
day of first flatus
Measured: upto 24 hours
postoperative nausea and vomiting
frequency of postoperative nausea and vomiting
Measured: upto 24 hours
pain score by the visual analogue scale with score minimum 0 and maximum 10
pain score from the scale that is higher score indicate worse and lower score indicate good
Measured: upto 48 hours
complications related to the intervention
yes or no
Measured: upto 2 weeks
readmission rate
readmission rate
Measured: upto 21days
mortality rate after the procedure
postoperative mortality rate and number
Measured: 5 to 7 days
Total hospital cost
total hospital cost
Measured: 3to 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start1 Jun 2025
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ERASStudies 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
- Model description
- Patients between the age of 18-70 years, who will diagnosed with cervical tumors, uterine tumors or ovarian tumors, and admitted for surgical management will be eligible for enrollment.
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JANNAT FERDOUS, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Investigators
- JANNAT FERDOUS, Principal investigator, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07087366
- Sponsor's protocol ID
- 1139
- Status last verified
- Aug 2025
- First submitted
- 17 Jun 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Recovery After Surgery(ERAS) Pathway Following Gynecological Oncology Surgery in a Tertiary Level Hospital:A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07087366
- Acronym / sponsor ID
- 1139
- Keywords
- RCT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 28 Jul 2025 (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.
Enhanced recovery after surgery (ERAS) protocols are multimodal perioperative care pathways designed to achieve early recovery after surgical procedures by maintaining preoperative organ function and reducing the profound stress response following surgery.
The principle of ERAS is to optimize the patient's health before surgery, minimize stress to the body, and restore function to normal rapidly by taking steps before, during, and after surgery, to decrease the length of stay in the hospital, reduce recovery time, prevent complications, readmissions, same day discharge (SDD) and patient's satisfaction.
The aim of this study is to introduce the ERAS recommendations into the management of gynaecological surgical procedures in compared to conventional procedures.
After taking permission from Institutional Review Board (IRB) of BSMMU, the proposed study will be started. After taking informed written consent and matching eligibility criteria, a total 160 patients will be selected in this prospective randomized control study. This study will be conducted in the Department of gynecological oncology, BSMMU for two years from April 2024 to March 2026. There will be two group in this study, patients of Group A will be selected for ERAS protocol from preoperative to postoperative event up to follow up. Patients of Group B will be selected for conventional method. Outcome of both procedure in terms of hospital stay, costs, requirement of analgesia and complications will be compared. Statistical analyses of the results will be obtained by using window-based computer software devised with Statistical Packages for Social Sciences (SPSS-25).
Detailed description
Over 234 million major surgical procedures are performed globally each year and despite advances in surgical and anaesthetic care, morbidity after abdominal surgery is still high. Fasttrack or enhanced recovery after surgery (ERAS) clinical pathways have been proposed to improve the quality of perioperative care with the aim of attenuating the loss of functional capacity and accelerating the recovery process.
The ERAS pathways reduce the delay until full recovery after major abdominal surgery by attenuating surgical stress and maintaining postoperative physiological functions. The implementation of the ERAS pathways has been shown to impact positively in reducing postoperative morbidity, and as a consequence, length of stay in hospital.
The concept of ERAS was first published by Engelman and colleagues in cardiac surgery in 1994. Subsequently, ERAS Society was formed in the early 2000s by a group of European surgeons (ERAS Society guidelines was formed). Early studies were primarily focused on colorectal surgery, and in 2003 (Marx and colleagues) this concept was demonstrated in gynecologic oncology. The first ERAS guidelines in gynecologic oncology were published in 2016. Updated guidelines for ERAS in gynecologic oncology were published in 2019.
Components of ERAS are preoperative, intraoperative and post operative. Pre-operative component includes: Patient education regarding the surgery and the expected post-operative course, ensuring the patient is as healthy as possible prior to surgery through exercise \& weight loss, optimal pre-operative fasting guidelines that will allow solid food until 6 hours pre-operatively and intake of clear fluids until 2 hours prior to surgery. A Cochrane review reported that preoperative carbohydrate treatment was associated with reduced post-operative insulin resistance, enhanced return of bowel function, and shorter hospital stay with no effect on post-operative complication rates, length of hospital stay (LOSH) and its related costs. In recent years, several studies have highlighted the impact of the anaesthetic management on postoperative morbidity and mortality.
In view of the evidence that many elements of the ERAS programme published by the ERAS Society in 2009 are of related to anaesthetic care, it is imperative that guidelines on perioperative care include recommendations approved by an interdisciplinary team comprising anaesthesiologists and surgeons.
Most of the ERAS elements have been already discussed extensively, specifically for different types of surgical procedures, as well the quality of evidence supporting each ERAS element. It must be acknowledged that evidence supporting some of the ERAS elements still remains controversial. The historical significance of ERAS has been established since 1990 (REF) in general surgery, orthopaedics and urology. ERAS resulted in increased patient satisfaction, shorter hospital stays, reduced postoperative complications and reduced treatment costs, which contribute to increased hospital productivity.
There are a number of reports in the literature on the implementation of the ERAS programme into the care of gynaecological patients . Minimally invasive surgery is advisable in ERAS protocol in order to reduce surgical complications, wound infections, incidence of deep vein thrombosis and hospital stay.
There is a strong opinion that the majority of gynaecological procedures can be done without mechanical bowel preparation (enema) .
One of the demonstrated advantages of restricting the administration of intravenous fluids to surgical patients is the reduction of pulmonary complications . Another recommendation is the avoidance of opioids, which can cause nausea, vomiting and ileus .
Regarding Health Economics Benefits; Direct medical and indirect non-medical costs were significantly lower in the ERAS group, there was a significant reduction in total hospital stay, intravenous fluid use, complications and duration of epidural use in the ERAS group, The implementation of an ERAS program causes overall cost-saving of roughly $6900 per patient.
The aim of this study is to introduce the ERAS recommendations into the management of gynaecological procedures in our institution.
Rationale of the research:
Optimization of care in the perioperative period is increasingly being recognized as a means of improving outcomes after surgery. This began with the concept of enhanced recovery after surgery (ERAS) which described pre, intra, and post-operative factors to improve patient outcomes after surgery.
Following recommendations are advocated for preoperative preparation while doing major gynaecological oncological surgery: No preoperative mechanical bowel preparation as several studies have shown that oral antibiotics alone compared with no bowel preparation significantly reduced post-operative infectious morbidity including anastomotic leaks. ERAS protocol also recommend that all gynecologic oncology patients who undergo major surgery > 30 min should receive dual VTE mechanical prophylaxis and chemoprophylaxis. Perioperative prophylaxis should begin before the induction of anesthesia Intra-operative component includes use of multimodal and opioid-sparing analgesia, targeting perioperative goal-directed fluid therapy that reduces length of stay \& complications in high-risk patients undergoing abdominal surgery . Minimally invasive surgery remains an important tenet of ERAS and is recommended for appropriate patients when long-term oncologic outcomes are similar, where expertise and resources are available .
Post-operative component includes adequate pain control, early mobilization, early oral intake. A regular diet within the first 24 hours after gynecologic/oncology surgery is recommended, High protein diets may be considered, multi-disciplinary post-operative patient follow-up is required. Patient Reported Outcomes, including functional recovery and audit also one of the most important component of ERAS protocol that allow institutions to monitor, understand, and compare functional recovery in a patient-centered fashion.
But the conventional protocol that has been practicing for our patients so far is complicated as it involves preoperative mechanical bowl preparation that stats 3 days prior to surgery, preoperative and post operative use of opioids and more analgesics.
So, the conventional protocol causes more length of hospital stay, patients discomfort and less turn over that ultimately increase hospital cost for the patients.
There are limited study done to evaluate the optimization of ERAS protocol in Bangladesh and no study was performed so far in gynaecological cancer surgery. This study is done to determine the ultimate outcome of gynaecological oncology surgery following ERAS protocol and compare it with the conventional method in BSMMU .
Hypothesis:
The perioperative and post operative in patients undergoing gynaecological cancer surgeries following ERAS protocol is better than that of the conventional method.
Objective:
General objective:
To find out the perioperative and postoperative outcome in patients undergoing gynaecological cancer surgeries following ERAS protocol (Group A) compared with conventional method(Group B).
Specific objectives:
- To compare the perioperative pain score, day of first flatus, any complications in patients undergoing gynaecological cancer surgeries following ERAS protocol and in patients following conventional protocol.
- To compare the costs , hospital stay, complications, readmission rate, reoperation rate, postoperative mortality in both the groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients between the age of 18-70 years, who will diagnosed with cervical tumors, uterine tumors or ovarian tumors, and admitted for surgical management will be eligible for enrollment.
| Arm | Type | Receives |
|---|---|---|
| ERAS group | Experimental | Procedure: ERAS protocolPreoperative: * Education * No bowel preparation * Fasting up to 6 h before surgery * Oral carbohydrate solution (50 G in 200 mL water, 2 hours before surgery Day of surgery: * Insertion of Foley catheter * Antiembolic stockings * Fluid restriction (4-5 L) * 0.2% Bupivacaine during incision closure * Sip of water 2 hours later after surgery * Postoperative LMWH injection * Antiembolic stockings * Foley removal as early as possible * Drain removal as early as possible * Ambulation at morning \& continue and encourage ambulation * Fluid restriction (1-2 L * NSAIDs/ Paracetamol bid for 3 days for analgesia IV PCA (Epidural) * Semifluid diet in POD1 * Soft blended diet in POD2 |
| Conventional Group | No intervention | –Before and after Surgery: * Bowel preparation * Midnight fasting * Insertion of Foley catheter * Antiembolic stockings * Fluid (5-6L) * Fluid (2L-3L) * Semifluid diet after first flatus Post-operative: * Use of Narcotic analgesia * Prolonged immobilization * NPO till bowel sound * Prolonged catheterization |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients between the age of 18-70 years,
- diagnosed case with cervical, uterine or ovarian cancer,
- Admitted for surgical management .
Key exclusion criteria (3 listed)
- Patients with severe comorbidity, including DM,CRD,CLD
- patients with American Society of Anesthesiologists risk ≥ 4,
- severe organ dysfunction or failure.
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 |
|---|---|---|
| ERAS protocolProcedure: ERAS protocol | Procedure or surgery | ERAS group |
Primary outcome
hospital stay
Time frame: 3 to 4 days
duration of hospital stay in ERAS group
7 secondary outcomes
Day of first flatus
Time frame: upto 24 hours
postoperative nausea and vomiting
Time frame: upto 24 hours
pain score by the visual analogue scale with score minimum 0 and maximum 10
Time frame: upto 48 hours
complications related to the intervention
Time frame: upto 2 weeks
readmission rate
Time frame: upto 21days
mortality rate after the procedure
Time frame: 5 to 7 days
Total hospital cost
Time frame: 3to 4 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Individual participant dataSharing planned: No
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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.
JANNAT FERDOUS principal investigator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERAS protocol in people with ERAS and Cancer, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
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 3 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: looking for participants now, as of the sponsor's last update on 7 Aug 2025. 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 Bangladesh. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact DR.Jannatul Ferdous, professor (01711607919, jannat@bsmmu.edu.bd), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hospital stay (time frame: 3 to 4 days). 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 7 Aug 2025.