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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   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 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
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 
Designation  Director 
Affiliation  Salasar Nursing Home 
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 of Contact Person
Scientific Query  
Name  Dr Niranjan Agarwal 
Designation  Director 
Affiliation  Salasar Nursing Home 
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 of Contact Person
Public Query  
Name  Mr Hitesh Thakur 
Designation  Deputy General Manager  
Affiliation  Croissance Clinical Research 
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  
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  
Name of Principal Investigator  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
MAHARASHTRA 		 9820541923

nda@salasarhospital.com 
 
Details of Ethics Committee  
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  (1) ICD-10 Condition: K629||Disease of anus and rectum, unspecified,  
 
Intervention / Comparator Agent  
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  
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" 
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)
Modification(s)  		 20/12/2020 
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="10"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
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.
 
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