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CTRI Number  CTRI/2017/03/008019 [Registered on: 06/03/2017] Trial Registered Retrospectively
Last Modified On: 26/05/2017
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Herbal medicine]  
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Role of Qlin® (Natural cream spray) for external use in treating the patients with first to third degree haemorrhoids 
Scientific Title of Study   A randomized prospective double blind, two arm, parallel assignment, placebo controlled study to evaluate the safety and efficacy of Qlin® in patients with first to third degree 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 Manjunath G 
Designation  HOD- General Surgery 
Affiliation  Sapthagiri Institute of Medical Sciences and Research center 
Address  Sapthagiri Institute of Medical Sciences and Research Center, Chikkasandra, Hesaraghatta Main Road, Bangalore

Bangalore
KARNATAKA
560090
India 
Phone  9731799114  
Fax    
Email  dr.bgmanjunath@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Baburao Vikram 
Designation  General Manager 
Affiliation  Bio Agile Therapeutics Pvt. Ltd. 
Address  Bio Agile Therapeutics Ltd Niran Arcade 563/564 Ground Floor New Bel Road Bangalore INDIA

Bangalore
KARNATAKA
560094
India 
Phone  9620087715  
Fax    
Email  pm@bioagiletherapeutics.com  
 
Details of Contact Person
Public Query  
Name  Divya Chandradhar 
Designation  Director 
Affiliation  Bio Agile Therapeutics Ltd. 
Address  Bio Agile Therapeutics Ltd Niran Arcade 563/564 Ground Floor New Bel Road Bangalore INDIA

Bangalore
KARNATAKA
560094
India 
Phone  9538961761  
Fax    
Email  divya@bioagiletherapeutics.com  
 
Source of Monetary or Material Support  
Dobra Dela d.o.o Na HerÅ¡i 11 1000, Liubliana Slovenia 
 
Primary Sponsor  
Name  Dobra Dela doo 
Address  Dobra Dela doo, Na HerÅ¡i 11 1000, Liubliana Slovenia, EU  
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Manjunath BG  Sapthagiri Institute of Medical Sciences and Research Center  Plot No. 15, Chikkasandra, Hesaraghatta Main Road, Bengaluru- 560090
Bangalore
KARNATAKA 		 9731799114

dr.bgmanjunath@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee Sapthagiri Institute of Medical Sciences and Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  hemorrhoids (first, second or third degree,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo  Placebo consist of base except active ingredients 
Intervention  Qlin natural  Qlin® product consist of following natural plant extracts Alantoin, Quercus alba bark extract, Hamamelis virginiana bark/leaf extract, and Aesculu hipocastanum seed extract (Known herbal remedies for varicosa veins and Hemerroids). Auxillary ingredients are Panthenol, Mentha piperita oil, Lavandula hibrida grosso Herb oil, Citrus aranteum, and Anthemis nobilis flower oil. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Adult subjects who are able to give written informed consent.
2. Male or female subjects, at least 18 years of age with a diagnosis of hemorrhoids (first, second or third degree).
3. Except hemorrhoids (first, second or third degree), the subjects are judged to be in good general health, based on medical history, physical examination.
4. If female of childbearing age, willing to use an acceptable form of birth control measure, should be stable since last 3 months prior to baseline and throughout 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 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 year 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.
 
 
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 
Change in the following symptoms Pain, tenesmus, pruritus and anal discharge as assessed by the subject at day 30
Change in the following objective signs
Congestion, oedema, and exudation as assessed by the investigator
Change in overall assessment of disease condition as assessed by the subject on a 10 cm Visual Analogue Scale
 		 Day 1, Day 10, Day 20 and Day 30 
 
Secondary Outcome  
Outcome  TimePoints 
Physical Examination
Vital Signs: Pulse rate, blood pressure and body temperature
Urine Pregnancy Test
Adverse Event Assessments
 		 Day 1, Day 10, Day 20 and Day 30. 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
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)   08/02/2017 
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)  Closed to Recruitment of Participants 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   This study is designed to be a randomized prospective double blind, two arm, parallel assignment, placebo controlled study to evaluate the efficacy and safety of Qlin® in patients with First, Second or Third degree haemorrhoids. A double blind parallel group randomized placebo controlled study design was chosen as an appropriate study design to achieve unbiased treatment in this clinical trial. This clinical study was planned to be conducted over a period of up to 60 days, of which 30 days before visit 1 was considered to be “Screening Period” and the treatment period starts from Day 1, which visit 1. Visit 1 is followed by three consecutive visits scheduled ay Day 10 (Visit 2), Day 20 (Visit 3) and Day 30 (Visit 4).  
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