| CTRI Number |
CTRI/2018/10/016046 [Registered on: 16/10/2018] Trial Registered Prospectively |
| Last Modified On: |
27/12/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial of a cream to be applied locally for adult subjects with painful growth in the anal region. |
|
Scientific Title of Study
|
A Prospective open randomized, parallel group clinical study to evaluate the efficacy and safety
of topical treatment in the management of Hemorrhoids in adults. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shivaraj KK |
| Designation |
Principal Investigator |
| Affiliation |
Pristine Hospital |
| Address |
Pristine Hospital
No 877,
Department of Medicine, Ground Floor,
Modi Hospital Road West of Chord 2nd Stage Ext
Bangalore
KARNATAKA
560086
India |
| Phone |
|
| Fax |
|
| Email |
shivarajkk09@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,
Cheif Executive Officer,
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.
Cheif Executive Officer,
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 Shivaraj KK |
Pristine Hospital |
Department of Internal Medicine,
No 877,
Modi Hospital Road West of Chord Road 2nd Stage Extension
Bangalore
KARNATAKA |
9035209089
shivarajkk09@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Pristine Hospital and Research Centre Pvt Ltd |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K641||Second degree hemorrhoids, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ALOE BARBADENSIS LEAF JUICE 10X DECOLORIZED
OLIO JOJOBA GOLDEN |
5gm of the cream to be applied locally 2 times a day in the anal region for 14 days. |
| Comparator Agent |
Nil |
Nil |
|
|
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, between 18 years of age and 70 years age with a diagnosis of haemorrhoids (first or
second degree).
3. Except hemorrhoids (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.
|
|
| 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 fistula
3. Subjects with associated anal fissures and/or infective anal pathology.
4. 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.
5. Subjects who, in the opinion of the investigator, are mentally incapacitated such that informed
consent cannot be obtained.
6. Subjects with clinically significant co-morbid condition that in the opinion of the investigator
could affect the efficacy and safety outcome of the study.
7. Patients under treatment with other topical therapy for haemorrhoidal syndrome.
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. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Change in the following subjective symptoms: pain, tenesmus, pruritus and anal discharge.
2.Improvement of pain during defecation
3.Change in overall assessment of disease as assessed by the subject on a 10 cm Visual Analogue Scale (VAS).
4.Change in the following objective signs: Congestion, oedema, and exudation
5.Overall treatment satisfaction questionnaire. |
Screening, Day 0,7 and 14. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Physical Examination: Examination includes areas such as perianal skin should be assessed.
2.Any reports of adverse or serious adverse events during the treatment period.
3.Significant change in laboratory parameters Any abnormal vital signs. |
Screening, Day 0,7 and 14. |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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
|
N/A |
|
Date of First Enrollment (India)
|
31/10/2018 |
| 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="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This clinical study is being planned to assess the efficacy and safety of topical treatment (tube consisting of the cream for topical administration) in subjects with Haemorrhoids with that of subjects who are only on restricted diet. 45 subjects with 1st and 2nd degree haemorrhoids will be included in this study for a period of 14 days. The treatment will check for change in the following subjective symptoms: pain, tenesmus, pruritus and anal discharge as assessed by the subject at day 7 and 14 (categorized as none, mild, moderate and severe). Symptoms will be recorded by each subject daily in a diary distributed at Visit 1. Improvement of pain during defecation (due to lubricant action of the product). Collected by daily questionnaire.Change in overall assessment of disease as assessed by the subject on a 10 cm Visual Analogue Scale (VAS) at day 14; where 0=Best Ever and 10=Worst Ever. Collected by daily questionnaire.Change in the following objective signs: Congestion, oedema, and exudation as assessed by the investigator at day 7 and 14 (categorized as absent or present). The objective of this study is to evaluate the Efficacy and safety of topical treatment plus restricted diet versus restricted diet alone in subjects with Haemorrhoids. Type of the study - Prospective open label Randomized controlled for parallel groups. |