| CTRI Number |
CTRI/2019/10/021832 [Registered on: 31/10/2019] Trial Registered Prospectively |
| Last Modified On: |
16/12/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical study for adult subjects for a cream which has to be applied locally for painful growth in the anal place. |
|
Scientific Title of Study
|
A randomized double blind placebo controlled Safety and efficacy study of Lenoid, a topical treatment for symptoms relief in patients with haemorrhoids |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sreedhara V |
| Designation |
Principal Investigator |
| Affiliation |
SPARSH Hospital |
| Address |
SPARSH Hospital
No. 146, Infantry Road, Opposite to Police Commissioners Office, Bangalore
Bangalore
India
Bangalore
KARNATAKA
560001
India |
| Phone |
|
| Fax |
|
| Email |
sreedhara142@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepa Subramanian |
| Designation |
Chief Executive Officer |
| Affiliation |
Syncretic Clinical Research Services Pvt. Ltd. |
| Address |
Syncretic Clinical Research Services Pvt Ltd
No 32 Door No 4 (Old No.38)
5th cross 11th Main
Vasanthnagar.
Bangalore
KARNATAKA
560052
India |
| Phone |
|
| Fax |
|
| Email |
deepa@syncretic.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepa Subramanian |
| Designation |
Chief Executive Officer |
| Affiliation |
Syncretic Clinical Research Services Pvt. Ltd. |
| Address |
Syncretic Clinical Research Services Pvt Ltd
No 32 Door No 4 (Old No.38)
5th cross 11th Main
Vasanthnagar.
Bangalore
KARNATAKA
560052
India |
| Phone |
|
| Fax |
|
| Email |
deepa@syncretic.in |
|
|
Source of Monetary or Material Support
|
| Giellepi Spa Via B, Cellini 37 Lissone (MB) - 20851 Italy |
|
|
Primary Sponsor
|
| Name |
Giellepi Spa |
| Address |
Via B, Cellini 37
Lissone (MB) - 20851
Italy |
| Type of Sponsor |
Other [[Manufacturer, Limited Company] ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sreedhara |
SPARSH Hospital |
SPARSH Hospital, Ground Floor,Department of Gastroenterology, No. 146, Infantry Road, Opposite to Police
Commissioners Office, Bangalore Bangalore India
Bangalore
KARNATAKA
560001
India
Bangalore
KARNATAKA |
9900569760
sreedhara142@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee SPARSH Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K640||First degree hemorrhoids, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Oryza sativa germinated grain 10% w/w
Limnanthes alba seed oil,
Butyrospermum parkii butter extract 5 % w/w
|
5gm of the single use cream to be applied locally 2 times a day in the anal region for 14 days. |
| Comparator Agent |
Placebo |
5gm of the single use cream to be applied locally 2 times a day in the anal region for 14 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects willing to give written informed consent.
2.Male or female subjects, more than 18 years of age with a diagnosis of haemorrhoids (first or second degree). 

3.Except haemorrhoids (first or second degree), the subjects are judged to be in good general health, based on medical history, physical examination. 

4.If female of childbearing age, they should be willing to use an acceptable form of birth control measure. They should be stable since last 3 months prior to baseline 
and throughout the study. 

5.Subjects accepting to be on controlled and balanced diet (with exclusion of 
some foods including hot chili, pepper, chocolate, alcoholic drinks, fried foods). Tea and coffee will be restricted to not more of 2 cups per day.
6.Subjects who were on phlebotonic drugs but who are not on the medications since 2 months before the recruitment can be included in the study.
|
|
| ExclusionCriteria |
| Details |
1.Pregnant and lactating women and women in post-partum period of up to 6 weeks. 

2.Subjects with a history of permanent anal prolapse and/or anal fissures and/or infective anal pathology. 

3.Subjects with previous history of surgery for anorectal disease (within 5 years) or any other procedures (including but not limited to injection sclerotherapy, rubber band ligation, photocoagulation, cryotherapy etc) within 2 years of enrolment into the trial. 

4.Subjects who, in the opinion of the investigator, are mentally incapacitated such that informed consent cannot be obtained. 

5.Subjects with clinically significant co-morbid condition that in the opinion of the investigator could affect the efficacy and safety outcome of the study. 

6.Patients under treatment with other topical therapy for haemorrhoidal syndrome.
7.Patients under treatment with plebotonic drugs or phlebotonic dietary supplements (i.e. diosmin etc.).
8.Subjects participating in any other clinical trial currently or if he/she has completed the trial participation less than 3 months from screening for the current study.
9.Presence of disease states that could affect safety and efficacy 
evaluation, such as hepatic (e.g., cirrhosis with Child-Pugh Class B or C or MELD score > 9), renal (e.g., requiring dialysis), gastrointestinal (e.g., acute or chronic diverticulitis, irritable bowel syndrome with epigastric pain as a predominant symptom or active inflammatory bowel disease), hematologic, neurologic or brain disorders (e.g., strokes, and brain injury), psychiatric (e.g., bipolar disorder, severe active depression, severe active anxiety), or any other significant condition which, in the opinion of the Investigator, could confound or interfere with evaluation of efficacy, safety, or tolerability of the investigational drug, or prevent compliance with the study protocol.

10.Subjects unwilling to sign the inform consent document.
11.Any condition that in the opinion of the investigator does not justify the subjects
inclusion for the study.
12.Known hypersensitivity to, or intolerance of, investigational product or any excipient.
13.During the course of the study no other medications should be consumed. Only rescue medications to be used with the recommendatuons from the Pricipal Investigtor and this should be recorded in the CRF.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time taken for 35% reduction (compared to baseline) of the overall score (total sum of each individual score of Questionnaires: Appendix G, Appendix H and Appendix I) of active product when compared to placebo. |
Screening Day 0 7 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Reduction of the score of each symptom at day 7 and 14 .
2.Reduction of the overall score (total sum of each individual score of the following symptoms: pain, tenesmus, pruritus and anal discharge .
3.Number of subjects with complete symptomatic resolution at day 14.
4.Number of subjects with a 35% reduction in the overall symptom score compare to the baseline of active product when compared to placebo.
|
Screening Day 0 7 14 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
10/01/2020 |
| Date of Study Completion (India) |
13/02/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="20" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Randomized, double blind, placebo controlled studies are considered to be of the highest standards for the assessment of efficacy and safety of a study medication; accordingly the same design is used for this study. Patients with hemorrhoids (1st and 2nd degree) will be enrolled in the study to assess the safety and efficacy of LENOID (tube consisting of the cream for topical administration)
Patients with severe state of disease (4th Degree) will not be enrolled in the study as this is a placebo controlled trial and half of the patients in the study will not be receiving any active treatment. 60 patients (male and female aged above 18 years) will be enrolled into the study. There will be 2 Groups in the study. First group consists of 30 patients receiving LENOID and the Second group is of 30 patients receiving matching Placebo. Both the groups will be on a controlled diet for the entire study duration of 14 days.
Type of study: A prospective, randomized, double blind, parallel, placebo controlled, single-centre, clinical study.
Study groups
Test group: LENOID (tube consisting of the cream for topical administration) of GIELLEPI S.p.A. (Italy)
Reference group: Matching Placebo
|