| CTRI Number |
CTRI/2015/02/005580 [Registered on: 25/02/2015] Trial Registered Prospectively |
| Last Modified On: |
17/05/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To Evaluate the Efficacy and Safety of Lactitol and Psyllium Alone and in Combination in Treatment of Constipation. |
|
Scientific Title of Study
|
A Prospective, Randomised, Double-Blind, Placebo-Controlled, 4 week Parallel Group Study to Evaluate the Efficacy and Safety of Lactitol and Psyllium Alone and in Combination in Treatment of Constipation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| DSO-01, Version 1.0 dated 09 June 2014. |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
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| Affiliation |
|
| Address |
|
| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
|
| Name |
Dr Subhranshu Nayak |
| Designation |
Medical Monitor |
| Affiliation |
Max Neeman Medical International |
| Address |
Max Neeman Medical International
Max House, 1st Floor
1, Dr. Jha Marg, Okhla Phase-III
New Delhi-110020, India
South
DELHI
110020
India |
| Phone |
91-9643430098 |
| Fax |
91-11-26322846 |
| Email |
Subhranshu.Nayak@maxneeman.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shariq Anwar |
| Designation |
Head Operations |
| Affiliation |
Max Neeman Medical International |
| Address |
Max Neeman Medical International
Max House, 1st Floor, 1, Dr. Jha Marg, Okhla Phase III
New Delhi - 110 020, India
South
DELHI
110020
India |
| Phone |
91-9810979215 |
| Fax |
91-11-40548168 |
| Email |
Shariq.Anwar@maxneeman.com |
|
|
Source of Monetary or Material Support
|
| Danisco Sweeteners Oy,
Address: Sokeritehtaantie 20 FIN-02460 Kantvik, Finland |
|
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Primary Sponsor
|
| Name |
Danisco Sweeteners Oy |
| Address |
Sokeritehtaantie 20
FIN-02460 Kantvik, Finland
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
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Details of Secondary Sponsor
|
| Name |
Address |
| Max Neeman Medical International |
Max Neeman Medical International,
Max House, 1st Floor, 1, Dr. Jha Marg,
Okhla Phase III, New Delhi - 110 020, India
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Dhiman Sen |
Apollo Gleneagles Hospitals |
Apollo Gleneagles Hospitals, Department of Medicine
58, Canal Circular Road, 700054, India
Kolkata
WEST BENGAL |
91-9831228660
033-232-01739
dhimansen2004@yahoo.com |
| Dr Kamlesh Kumar Gupta |
King George’s Medical University |
King George’s Medical University, Department of Medicine, 1st Floor, Chowk, Lucknow, Uttar Pradesh- 226003
Lucknow
UTTAR PRADESH |
91-9415815093
kamleshKGMU@rediffmail.com |
| Dr Sandeep Garg |
Maulana Azad Medical College & Associated Lok Nayak Hospital |
Maulana Azad Medical College & Associated Lok Nayak Hospital
Taneja Block, Department of Medicine, 1st Floor, Room No. 120,
Bahadur shah Jafar Marg,
110002, India
New Delhi
DELHI |
91-9968604280
drsandeepgargmamc@gmail.com |
| Dr Shyam Sundar Sharma |
S.M.S Medical College and Attached Hospital |
S.M.S Medical College and Attached Hospital, Department of Gastroenterology, 2nd Floor, J.L.N Marg, Jaipur, Rajasthan- 302004
Jaipur
RAJASTHAN |
91-9829051359
shyamsharma4@rediffmail.com |
| Dr Mukund Penurkar |
Sanjeevan Hospital |
Sanjeevan Hospital, Department of Medicine,
Plot No 23,
Off. Karve Road, Erandwane,
411 004
India
Pune
MAHARASHTRA |
020-67250000
020-67250015
mukund.penurkar@gmail.com |
| Dr Mandhir Kumar |
Sir Ganga Ram Hospital |
Sir Ganga Ram Hospital,
Department of Gastroenterology, 3rd Floor, Old Building, Marg,
Rajinder Nagar, 110060, India
Central
DELHI |
91-9811214449
mandhirkr@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Ethics Committee Sanjeevan Hospital |
Approved |
| Ethics Committee Sir Ganga Ram Hospital Ethics Committee |
Approved |
| Independent Ethics Committee, Indian Fertility Society situated at Department of Obstetrics and Gynaecology, MAMC and Lok Nayak Hospital |
Approved |
| Institutional Ethics Committee, Apollo Gleneagles Hospital |
Approved |
| Institutional Ethics Committee, King George’s Medical College |
Approved |
| The Ethics Committee, S.M.S Medical College and Attached Hospital |
Approved |
|
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Regulatory Clearance Status from DCGI
|
| Status |
| No Objection Certificate |
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K929||Disease of digestive system, unspecified, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Treatment group 1:Lactitol alone (10 g) |
1 powder sachet daily for 4 weeks (treatment phase) starting from baseline. |
| Intervention |
Treatment group 2: Psyllium alone (3.5g) |
1 powder sachet daily for 4 weeks (treatment phase) starting from baseline. |
| Intervention |
Treatment group 3:Combination of Psyllium (3.5g) & Lactitol (10g) |
1 powder sachet daily for 4 weeks (treatment phase) starting from baseline. |
| Comparator Agent |
Treatment group 4:Placebo |
1 powder sachet daily for 4 weeks (treatment phase) starting from baseline. |
|
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Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female of age between 25 and 65 years
2. BMI between 18.5 and 29.9 kg/m2
3. Safety Blood and Urine tests without clinical significance
4. Self-reported constipation ≤ 3 stools per week for the last 3 months and during the run-in period
5. 80 % compliance with study product during the run-in period
6. Ability of the participant (as evaluated by the investigator) to comprehend the full nature and purpose of the study including possible risks and side effects
7. Consent to the study and willing to comply with study product and methods
8. Willingness to maintain a stable diet throughout the study
|
|
| ExclusionCriteria |
| Details |
1. Daily consumption of probiotics and prebiotics within 2 weeks prior of screening and during the run-in period
2. Use of laxative, fibre supplement, or other medications for treating constipation (e.g. prokinetic groups) within 2 weeks of screening and during the run-in period
3. Planned major changes in life style (i.e. diet, dieting, exercise level, travelling)
4. Pregnant or breastfeeding women; women planning to become pregnant during the study months.
5. Women after giving birth in the last 3 months
6. Known allergies to any substance in the study products
7. History of alcohol or drug abuse
8. Participation in a clinical trial with an investigational product or drug within 3 months prior to screening
9. Medications that exclude from participating in the study include:
• antibiotic use during one month prior to start of the study
• oral steroids use during one month prior to start of the study
• use of anticholinergic medication, pain medication that include opiates or morphine, weight loss medication, misoprostol, 5-HT3 receptor-antagonists, antacids with magnesium or aluminum, diarrhea medication, medication that accelerates the emptying of the stomach, sulfasalazine, colestyramine, sytostats, biological medication, and probiotic products
Note: medication that can be allowed if it has been consumed for at least 30 days on the same dose and is recorded during the trial include iron, antidepressants, statins, thyroxine, coxibes, acid medication (protein pump inhibitors (omeprazole, pantoprazole) and H2-blockers), inhaled steroids and other non-excluding medication that does not affect the study outcome measure in the clinicians opinion.
10. Diagnosed or suspected organic gastrointestinal disease (i.e. colitis, crohn’s disease, irritable bowel syndrome, celiac disease, bowel surgery, recurrent diverticulitis, megacolon, megarectum, and bowel obstruction) or severely impaired general health including cancer and cancer therapy
11. Likeliness to be noncompliant with the protocol, or to be unsuitable to the study by the investigator for any reason |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Centralized |
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Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Change in bowel movement frequency from baseline to Day 28 (EOS) within and between treatment groups. |
4 weeks. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Change in PAC-SYM score from baseline to Day 14 and Day 28 (EOS) within and between treatment groups |
2 & 4 weeks. |
| Change in stool consistency from baseline to Day 14 and Day 28 (EOS) within and between treatment groups, |
2 & 4 weeks. |
| Proportion of subjects with overall product satisfaction (on a scale of 1-5) at Day 28 (EOS), |
4 weeks. |
| Evaluation of food intake by 24 hour food recall at baseline and at Day 28 (EOS). |
baseline and at Day 28 (EOS). |
|
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Target Sample Size
|
Total Sample Size="172"
Sample Size from India="172"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
16/03/2015 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
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Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
A prospective, randomised, double-blind, placebo-controlled, 4 week
parallel group study to evaluate the efficacy and safety of Lactitol and Psyllium alone and in combination in treatment of constipation. The primary endpoint of the study is the Change in bowel movement
frequency from baseline to Day 28 (end of study [EOS]) within and between treatment groups. |