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CTRI Number  CTRI/2020/08/027248 [Registered on: 19/08/2020] Trial Registered Prospectively
Last Modified On: 27/09/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Clinical trial to study effect of hydrocortisone acetate suppositories  
Scientific Title of Study   A randomized double-blind, placebo-controlled, multi center, parallel group pilot study of the safety and efficacy of hydrocortisone acetate suppositories, 25 mg compared to placebo suppositories in the treatment of symptomatic internal hemorrhoids  
Trial Acronym   
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
HDCS1701 Version-5.1 Dated 13-Aug-2020  Protocol Number 
ID: NCT03335774  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Krunal Chauhan 
Designation  Medical Monitor 
Affiliation  Raptim Research Pvt.Ltd. 
Address  Raptim Research Pvt.Ltd, First floor , Clinical trial Department A-242, T.T.C., Industrial Area, Mahape M.I.D.C., Navi Mumbai.

Mumbai (Suburban)
MAHARASHTRA
400701
India 
Phone  02227781889  
Fax  02227781884  
Email  krunal.chauhan@raptimresearch.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Krunal Chauhan 
Designation  Medical Monitor 
Affiliation  Raptim Research Pvt.Ltd. 
Address  Raptim Research Pvt.Ltd, First Floor, Clinical Trial department A-242, T.T.C., Industrial Area, Mahape M.I.D.C., Navi-Mumbai.

Mumbai (Suburban)
MAHARASHTRA
400701
India 
Phone  02227781889  
Fax  02227781884  
Email  krunal.chauhan@raptimresearch.com  
 
Details of Contact Person
Public Query  
Name  Mustafa Pardiwala 
Designation  Sr. Project Manager 
Affiliation  Raptim Research Pvt.Ltd 
Address  Raptim Research Pvt.Ltd. First Floor, Clinical Trial Department A-242, T.T.C., Industrial Area, Mahape M.I.D.C., Navi Mumbai

Mumbai (Suburban)
MAHARASHTRA
400701
India 
Phone  02227781889  
Fax  02227781884  
Email  mustafa.pardiwala@raptimresearch.com  
 
Source of Monetary or Material Support  
Nivagen Pharmaceuticals, Inc. Address: : 3050 Fite Circle, Suite 100 Sacramento, CA 95827 Office: 916-364-1662 Cell: 720-469-0635 Fax: 844-270-3131 
 
Primary Sponsor  
Name  Nivagen Pharmaceuticals Inc 
Address  3050 Fite Circle, Suite 100 Sacramento, CA 95827 Office: 916-364-1662 Cell: 720-469-0635 Fax: 844-270-3131 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Not Applicable  Not Applicable 
 
Countries of Recruitment     India
United States of America  
Sites of Study  
No of Sites = 9  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Prasad Vaidya  Dr. Hedgewar Hospital  Dr. Hedgewar Hospital, General surgery, Room No: 2123, Ground floor, Near Gajanand Maharaj Mandir, Jawahar colony Road, Garkheda, Aurangabad - 431005.
Aurangabad
MAHARASHTRA 		 9822435519

vaidya@hedgewar.org 
Dr Martis Manohar  Father Muller Hospital  Father Muller Medical College, General surgery, Ground floor, Father Muller Road, Kankanady, Mangalore - 575002.
Dakshina Kannada
KARNATAKA 		 7760529829

mhmartis@gmail.com 
Dr Nitin Shanker Behl  Fortis Hospital  Fortis Hospital, Gastroenterology Department, 1st Floor, Mundian Kurd, Chandigarh Highway, Ludhiana - 141010.
Ludhiana
PUNJAB 		 8427000080

drnitinbehl@gmail.com 
Dr Ravindra BS  Fortis Hospital Ltd.  Fortis Hospital Ltd., Gastroenterology Department, Room No: 376 , 3rd Floor, 154/9, Bannerghata Road, Opposite to IIM-B, Bangalore - 560076.
Bangalore
KARNATAKA 		 9916636144

drravindrabs@gmail.com 
Dr Sandip Shah  Gastro Plus Digestive Disease Center  OPD No – 01, 3rd floor, D Block, Galaxy Bazaar, Sunrise Park Road, Vastrapur, Ahmedabad - 380054
Ahmadabad
GUJARAT 		 9909933006

drsandip8454@gmail.com 
Dr Rakesh kumar Adi  Gleneagles Global Hospitals  Clinical Research Room, 6th floor-1-82/83, Global Clinical Research Services (GCRS), Global Good Life Building, lakadi ka Pool, Hyderabad - 500004.
Hyderabad
TELANGANA 		 9985004650

rakeshkumaradi@yahoo.co.in 
Dr Vatsal Mehta  Kanoria Hospital & Research Center   301, Ground Floor, Clinical Research Department, Airport-Gandhinagar Highway,Village Bhat, Gandhinagar - 382428
Gandhinagar
GUJARAT 		 8424076444

vatsalmehta6387@gmail.com 
Dr Gaurish G Gadbail  Nirmal Hospital Private Limited  Nirmal Hospital Private Limited Room No. 108, First Floor, Adult OPD, Ring Road, Surat- 395002.
Surat
GUJARAT 		 9727712032

gaurish.g@gmail.com 
Dr Mahesh Sinnarkar  Pulse Multispecialty Hospital   Pulse Multispecialty Hospital, Sr. no 51/7/B/1, 1st Floor, Vishwa Arcade, Mumbai-Bangalore Highway, Narhe Ambegaon, Pune - 411041.
Pune
MAHARASHTRA 		 9850479900

drsinnarkar@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 9  
Name of Committee  Approval Status 
Dr Bamrs Dr Hedgewar Hospital Ethics Committee  Approved 
Ethics Committee of Pulse Multispecialty Hospital  Approved 
Father Muller Institutional Ethics Committee  Approved 
Fortis Hospital Ethics Committee, Bangalore  Approved 
Fortis Hospital Ethics Committee, Ludhiyana  Approved 
GastroPlus Ethics Committee  Approved 
Institutional Ethics Committee Gleneagles Global Hospitals  Submittted/Under Review 
Kanoria Ethics Committee  Approved 
Nirmal Hospital Pvt. Ltd. Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K922||Gastrointestinal hemorrhage, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Hydrocortisone Acetate Suppository  One Hydrocortisone Acetate Suppository, 25 mg is inserted into the anal canal twice daily (morning and evening) for 2 weeks (14 days) 
Comparator Agent  Placebo   One Placebo (Vehicle) Suppository is inserted into the anal canal twice daily (morning and evening) for 2 weeks (14 days) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  a. Have a diagnosis of internal hemorrhoids.
b. Is a male or female aged 18 years and older
c. Give voluntary consent to participate in the study following a full explanation of the nature and purpose of the study, by signing the IRB-approved Informed Consent document prior to any study specific evaluations.
d. Is willing to forego the use of non-prescription (OTC) and prescription medication or procedures for the treatment of hemorrhoidal disease and/or pain for the duration of the study.
e. Female Subjects of childbearing potential (excluding women who are or premenarchal, surgically sterilized (by hysterectomy) or postmenopausal for at least 1 year), in addition to having a negative urine pregnancy test, must be willing to use an acceptable form of birth control during the study from the day of the first dose administration to 30 days after the last administration of study drug. Subjects on hormonal contraception must be stabilized on the same type prior to enrollment in the study and must not change the method during the study.
f. All male Subjects must agree to use accepted methods of birth control with their partners. Female partners should use an acceptable method of birth control as described in the above Item
 
 
ExclusionCriteria 
Details  a. Has inflammatory bowel disease.
b. Is immunocompromised (e.g. receiving cancer chemotherapy, steroids, HIV positive).
c. Is a pregnant or nursing female.
d. Subjects who have unstable medical disorders that are clinically significant or have life-threatening diseases.
e. Subjects who consume excessive amounts of alcohol (greater than two drinks per day) or use drugs of abuse (including, but not limited to, cannabinoids, cocaine and barbiturates).
f. Positive urine screening for drugs of abuse or positive alcohol breath test.
g. Subjects who have participated in an investigational drug study (i.e., Subjects have been treated with an investigational drug) Lacks suitability for participation in this study for any reason in the opinion of the Investigator.
h. Clinically significant complete blood count (CBC), comprehensive metabolic panel (CMP), urinalysis or positive HIV, Hepatitis B, Hepatitis C.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
The objective of this study is;
1.To determine the effectiveness of Nivagen’s Hydrocortisone Acetate Suppositories in internal hemorrhoids.
2. To determine the safety and tolerability of Nivagen’s Hydrocortisone Acetate Suppositories
 		 Beginning of the study at Baseline and at the End of study which is considered as Week-4 
 
Secondary Outcome  
Outcome  TimePoints 
Not Applicable  Not Applicable 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="37" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)
Modification(s)  		 07/09/2020 
Date of Study Completion (India) 22/02/2021 
Date of First Enrollment (Global)  10/04/2019 
Date of Study Completion (Global) 05/03/2021 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
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   The study is a randomized, double-blind, placebo-controlled, multicenter, parallel group study of the safety and efficacy of Hydrocortisone Acetate Suppositories, in the treatment of internal hemorrhoids. Hydrocortisone is thought to improve the disease condition.  
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