CTRI Number	CTRI/2020/11/029298 [Registered on: 23/11/2020] Trial Registered Prospectively
Last Modified On:	05/03/2021
Post Graduate Thesis	No
Type of Trial	Interventional
Type of Study Modification(s)	Drug
Study Design	Single Arm Study
Public Title of Study	A scientific study to understand the effect of three combined medicine in the Management of Postoperative Symptoms in Patients who Underwent Surgical Treatment for Anorectal Disorders
Scientific Title of Study	A Prospective, Open Label, Single Center Clinical Study to Evaluate the Effectiveness and Safety of Fixed Dose Combination of Sucralfate 7% w/w, Metronidazole 1% w/w, and Lignocaine Hydrochloride 4% w/w in the Management of Postoperative Symptoms in Patients who Underwent Surgical Treatment for Anorectal Disorders
Secondary IDs if Any	Secondary ID  Registry  SMLGD001 Version No. 1.0 dated 15 Sep 2020  Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)	Name  Dr Niranjan Agarwal  Address  OPD Room No. 1, Salasar Nursing Home B-Ground Floor, Salasar Classic Near Nagar Bhavan Hall, Fatak Road Bhayandar (W), Dist Thane Thane MAHARASHTRA 401101 India  Phone  9820541923   Fax     Email  nda@salasarhospital.com
Details Contact Person Scientific Query	Name  Dr Niranjan Agarwal  Address  OPD Room No. 1, Salasar Nursing Home B-Ground Floor, Salasar Classic Near Nagar Bhavan Hall, Fatak Road Bhayandar (W), Dist Thane MAHARASHTRA 401101 India  Phone  9820541923   Fax     Email  nda@salasarhospital.com
Details Contact Person Public Query	Name  Mr Hitesh Thakur  Address  Plot No. 37, 2nd Floor, Matrusri Nagar-Gate No.5, Miyapur, Hyderabad Hyderabad TELANGANA 500049 India  Phone  9014546392   Fax     Email  hitesh@croissancecr.com
Source of Monetary or Material Support	Dr Niranjan Agarwal OPD Room No: 1, Salasar Nursing Home B-Ground Floor, Salasar Classic Near Nagar Bhavan Hall, Fatak Road Bhayandar (W), Dist Thane
Primary Sponsor Modification(s)	Name  Dr Niranjan Agarwal  Address  OPD Room No: 1, Salasar Nursing Home B-Ground Floor, Salasar Classic Near Nagar Bhavan Hall, Fatak Road Bhayandar (W), Dist Thane  Type of Sponsor  Other [Investigator Initiated Study]
Details of Secondary Sponsor	Name  Address  NIL  NIL
Countries of Recruitment	India
Sites of Study	No of Sites = 1   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Dr Niranjan Agarwal  Salasar Nursing Home  OPD Room No. 1, B-Ground Floor, Salasar Classic Near Nagar Bhavan Hall, Fatak Road Bhayandar (W), Dist Thane: 401101 Thane   9820541923 nda@salasarhospital.com
Details of Ethics Committee Modification(s)	No of Ethics Committees= 1   Name of Committee  Approval Status  Suraksha - Ethics Committee  Approved
Regulatory Clearance Status from DCGI	Status  Not Applicable
Health Condition / Problems Studied	Health Type  Condition  Patients  Disease of anus and rectum, unspecified
Intervention / Comparator Agent Modification(s)	Type  Name  Details  Intervention  CremaGel-H   FDC of Sucralfate 7% w/w, Metronidazole 1% w/w, and Lignocaine Hydrochloride 4% w/w Dosage: OD Route of Administration: Topical Application Duration of Therapy: 06 weeks  Comparator Agent  NIL  NIL
Inclusion Criteria	Age From  18.00 Year(s) Age To  64.00 Year(s) Gender  Both  Details  1. Male and female patients above 18 up to 64 years (both inclusive) 2. Patients who are undergoing surgery of hemorrhoids, fistulae, and / or anal fissures and are willing to take CremaGel-H for their postoperative symptoms 3. Patients willing to comply with study procedures and requirements 4. Patients willing to sign and date written informed consent form (ICF) to participate in the study
ExclusionCriteria	Details  1. History of inflammatory bowel disease, multiple fistulas, perianal dermatitis, proctitis, pulmonary or cardiovascular complications, or poorly controlled diabetes mellitus 2. Anal fistulas or anal fissure due to other causes such as Crohn disease, anal suppuration, and abscesses 3. Recent history (< 2 weeks) of chemotherapy 4. Diagnosis of active cancer, severe anemia, hypoalbuminemia, or immunocompromise 5. Past history of hypersensitivity to any of the ingredients of the study product, including Metronidazole, Lignocaine Hydrochloride, Sucralfate, or any other ingredient in the formulation 6. Patients on Class I anti-arrhythmic drugs or anticoagulant treatment as the toxic effects are additive and generally synergistic 7. Any past or present conditions / diseases that Investigator considers inappropriate for a patient to participate in the study 8. Patients who are unwilling to have an examination of anal wounds 9. Pregnant and lactating females
Method of Generating Random Sequence	Not Applicable
Method of Concealment	Not Applicable
Blinding/Masking	Open Label
Primary Outcome Modification(s)	Outcome  TimePoints  1. Proportion of patients with minimal clinically important difference (MCID) at 3 and 6 weeks after surgery where MCID is defined as reduction in 10 points on 100 mm VAS scale at 3 and 6 weeks after surgery from the baseline score 2. 2. Mean reduction in anal pain (on 100 mm VAS score) from baseline   at baseline, Week 3 and Week 6
Secondary Outcome	Outcome  TimePoints  Proportion of patients with complete wound healing   at 3 and 6 weeks after surgery  Mean reduction in • Itching on a 5-point scale ranging from score 1 (not present) to score 5 (unbearable)  from baseline to 3 and 6 weeks after surgery  Mean reduction in Bleeding score on a 5 point scale ranging from 1 episode per 2 weeks to 5 bleeding episodes per week  from baseline to 3 and 6 weeks after surgery  Mean reduction in • Burning on a 4 point scale ranging from score 0 (no symptoms) to score 3 (severe intensity symptoms)  from baseline to 3 and 6 weeks after surgery
Target Sample Size	Total Sample Size="50" Sample Size from India="50"
Phase of Trial	N/A
Date of First Enrollment (India) Modification(s)	20/12/2020
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="0" Months="10" Days="0"
Recruitment Status of Trial (Global) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Open to Recruitment
Publication Details Modification(s)	NIL
Brief Summary	Various studies have reported the effectiveness and safety of Sucralfate, Metronidazole and Lignocaine when used alone in the treatment of anorectal disorders. However, the combination of these 3 drugs (Sucralfate, Metronidazole with Lignocaine Hydrochloride) would be a viable option to provide the additive effects in terms of improvement in postoperative pain relief and wound healing. Hence, the current study is designed to evaluate the effectiveness and safety of FDC of Sucralfate 7% w/w, Metronidazole 1% w/w, and Lignocaine Hydrochloride 4% w/w (CremaGel-H by Abbott India Ltd) in terms of wound healing, postoperative pain, itching, bleeding, and burning after surgery of hemorrhoids, fistulae and anal fissures. This FDC has been approved by Drug Controller General of India for the treatment of bedsore, hemorrhoids, fistulae, and anal fissure on 23 August 2004. Croissance Clinical Research Pvt Ltd Hyderabad is providing Data Management support to this study.