Clinical trial to study effect of hydrocortisone acetate suppositories

Phase 2

Completed

Brief Summary: The study is a randomized, double-blind,placebo-controlled, multicenter, parallel group study of the safety and efficacyof Hydrocortisone Acetate Suppositories, in the treatment of internalhemorrhoids. Hydrocortisone is thought to improve the disease condition.

Recruitment & Eligibility

Inclusion Criteria

Have a diagnosis of internal hemorrhoids.
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.
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.
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.
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.

Exclusion Criteria

Has inflammatory bowel disease.
Is immunocompromised (e.g. receiving cancer chemotherapy, steroids, HIV positive).
Is a pregnant or nursing female.
Subjects who have unstable medical disorders that are clinically significant or have life-threatening diseases.
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).
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.
Clinically significant complete blood count (CBC), comprehensive metabolic panel (CMP), urinalysis or positive HIV, Hepatitis B, Hepatitis C.

Primary Outcome Measures

Name	Time	Method
The objective of this study is;	Beginning of the study at Baseline and at the End of study which is considered as Week-4
1.To determine the effectiveness of Nivagenâ€™s Hydrocortisone Acetate Suppositories in internal hemorrhoids.	Beginning of the study at Baseline and at the End of study which is considered as Week-4
2. To determine the safety and tolerability of Nivagenâ€™s Hydrocortisone Acetate Suppositories	Beginning of the study at Baseline and at the End of study which is considered as Week-4

Secondary Outcome Measures

Name	Time	Method
Not Applicable	Not Applicable

Locations (9): Dr. Hedgewar Hospital
🇮🇳
Aurangabad, MAHARASHTRA, India
Father Muller Hospital
🇮🇳
Kannada, KARNATAKA, India
Fortis Hospital
🇮🇳
Ludhiana, PUNJAB, India
Fortis Hospital Ltd.
🇮🇳
Bangalore, KARNATAKA, India
Gastro Plus Digestive Disease Center
🇮🇳
Ahmadabad, GUJARAT, India
Gleneagles Global Hospitals
🇮🇳
Hyderabad, TELANGANA, India
Kanoria Hospital & Research Center
🇮🇳
Gandhinagar, GUJARAT, India
Nirmal Hospital Private Limited
🇮🇳
Surat, GUJARAT, India
Pulse Multispecialty Hospital
🇮🇳
Pune, MAHARASHTRA, India
Dr. Hedgewar Hospital
🇮🇳Aurangabad, MAHARASHTRA, India
Dr Prasad Vaidya
Principal investigator
9822435519
vaidya@hedgewar.org