Prospective, Randomized, Observational Data Collection Study

To Compare 2 Commercially Available Proteolytic enzyme

combinations - Trypsin + Bromelain + Rutoside trihydrate vs
Trypsin + Chymotrypsin: An Investigator Initiated Study

CASE REPORT FORM

Subject number:
Subject initials:
Investigator Initiated Study/Physician Initiated Study
Phase 4
 Subject Initials: □□□ Subject Number: □□□
Screening/Baseline Visit (Day 01) __ __/__ __ __ /__ __ __ __
Date: (DD/MMM/YYYY)

Research Consent

Date of signing Research Consent (DD/MMM/YYYY) __ __/__ __ __ /__ __ __ __

Demographic Data

Patient date of Birth (DD/MMM/YYYYY) __ __/__ __ __ /__ __ __ __

Age (completed years)

Gender: Male Female

Details of Surgical Procedure (if applicable)

Date of procedure (DD/MMM/YYYY)

__ __/__ __ __ /__ __ __ __
Procedure:
Indication:

Type of Surgery :

INCLUSION CRITERIA
Sr. No. CRITERIA Yes No

As per Investigator opinion, suitable subjects who will be

prescribed
1. with Trypsin + Bromelain + Rutoside Trihydrate or Trypsin +
Chymotrypsin to reduce pain and edema post undergoing minor
surgery
2.
Willing to give written consent (data collection research informed
consent)
3.
Subjects ready to comply with study required visits.

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 Subject Initials: □□□ Subject Number: □□□
 Do not include the patient in the study, if answer to any of inclusion criteria is “No”.

EXCLUSION CRITERIA
Sr. No. CRITERIA Yes No

Subjects chronically receiving systemic or topical steroidal or non-

steroidal anti-inflammatory agents (including study drugs), or
1.
analgesics, and immunosuppressive agents within respective 5 half-
lives prior to administration of study drug.

Subject with known history of allergy, hypersensitivity, or intolerance

2.
to study drugs

Subject has history of use of recreational drugs within 12 months

3.
prior to receiving the study drugs

4. Pregnant or lactating women

Subject has received any investigational product or used any invasive

5. investigational medical device within 30 days before the planned first
dose of study drugs, or is currently enrolled in another
investigational study
 Do not include the patient in the study, if answer to any of the exclusion criteria is “Yes”.

Enrolment
Has the subject fulfilled all the Eligibility
Yes No
criteria?

If No Specify Reason and complete study completion page

_______________________________________________________________________________________

If yes, Date of enrolment: __ __ /__ __ __ /__ __ __ __

Trypsin + Bromelain + Rutoside

Treatment assigned
Trypsin + Chymotrypsin

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 Subject Initials: □□□ Subject Number: □□□
Follow up visits
Has the subject contacted Yes No

If No Specify Reason
_______________________________________________________________________________________

Is subject taking study drug as per

Yes No
protocol

Pain Intensity

Baseline Visit Follow up Visit 1 (Day 08) Follow up Visit 2 (Day 15)
Parameters
(Day 01) Visit date: Visit date:
No pain
Mild pain
Moderate pain
Severe pain

Swelling

Baseline Visit Follow up Visit 1 Follow up Visit 2

Parameters
(Day 01) (Day 08) (Day 15)

None

Mild

Moderate

Intense

Patient global impression Investigator global impression

Parameters Day 08 Day 15 Day 08 Day 15

Poor

Fair

Good

Very good

Excellent

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 Subject Initials: □□□ Subject Number: □□□
Adverse Events Yes No
Start date End date Severity Related Serious Action taken Outcome
(Yes / No) (Yes / No)

Concomitant Medication
Drug name Indication Dose Route Frequency Start date End date

STUDY COMPLETION
End of study date
__ __/__ __ __ /__ __ __ __
(DD/MMM/YYYY)

Date of last study medication dose

__ __/__ __ __ /__ __ __ __
(DD/MMM/YYYY)

Subject status Completed Study

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 Subject Initials: □□□ Subject Number: □□□
Discontinued/Withdrawn (If checked, select the appropriate reason
from the below list)

Reasons for Discontinuation/Withdrawal (Please check only ONE “Primary” reason)

Withdrew Consent

Non-compliance

Lost to Follow –up Date of last contact: __ __/__ __ __ /__ __ __ __

Adverse Event (Adverse Event term: ____________________________________________ )

Investigator’s Discretion (Specify)_________________________________________________________

Other (specify) _______________________________________________________________________

Statement: I certify that the entries on all pages of the case report form accurately and completely present
results of the examination, tests and evaluations performed on the dates specified. I was personally familiar
with the clinical presentation and progress of the study subject.

_________________________________ _______________________

Investigator signature Date

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