CTRI

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CTRI Number

CTRI/2024/02/062769 [Registered on: 16/02/2024] Trial Registered Prospectively

Last Modified On:

16/02/2024

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Ayurveda

Study Design

Randomized, Parallel Group, Multiple Arm Trial

Public Title of Study

Comparative study of Dvija Heal+ in wound management

Scientific Title of Study

A Randomized, Prospective, Comparative, Interventional, Three- Arm, Clinical Trial to Evaluate Efficacy and Safety of Topical Dvija Heal+ in comparison with 1% w/w Framycetin Cream (1% w/w) and Jatyadi Tel in Acute Wounds

Trial Acronym

Nil

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Hemant Toshikhane
Designation	Dean Faculty of Ayurved
Affiliation	Parul Institute of Ayurved
Address	Parul Ayurved Hospital, Parul University Campus, AP Limda Tal Waghodia, Vadodara GUJARAT 391760 India
Phone	8469496525
Fax
Email	drhemantt@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Harish Daga
Designation	Associate Professor Shalya Tantra
Affiliation	Parul Institute of Ayurved
Address	Parul Ayurved Hospital, Parul University Campus, AP Limda Tal Waghodia, Vadodara GUJARAT 391760 India
Phone	9413662079
Fax
Email	harish.daga26839@paruluniversity.ac.in

Details of Contact Person
Public Query

Name	Dr Shailesh Jaiswal
Designation	Associate Professor Shalya Tantra
Affiliation	Parul Institute of Ayurved and Research
Address	Khemdas Ayurved Hospital, Parul University, AP Ishwarpura Tal Waghodia, Vadodara GUJARAT 391760 India
Phone	9978608907
Fax
Email	shailesh.jaiswal26813@paruluniversity.ac.in

Source of Monetary or Material Support

Dvija Naturals Pvt Ltd

Primary Sponsor

Name	Dvija Naturals Pvt Ltd
Address	64/1 Shantai vale, Assagao, Goa 403507
Type of Sponsor	Pharmaceutical industry-Indian

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 2
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Shailesh Jaiswal	Khemdas Ayurved Hospital	OPD No 2, Ground Floor, Department of Shalya Tantra, Khemdas Ayurved Hospital, AP Ishwarpura, Tal Waghodia, 391760 Vadodara GUJARAT	9978608907 shailesh.jaiswal26813@paruluniversity.ac.in
Dr Harish Daga	Parul Ayurved Hospital	OPD No 106, Ground Floor, Department of Shalya Tantra, Parul Ayurved Hospital, Parul University, AP Limda, Tal Waghodia 391760 Vadodara GUJARAT	9413662079 harish.daga26839@paruluniversity.ac.in

Details of Ethics Committee

No of Ethics Committees= 2
Name of Committee	Approval Status
Institutional Ethics Committee (IEC) Parul Institute of Ayurved Parul University	Approved
Institutional Ethics Committee Parul Institute of Ayurved and Research	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:T148\|\|Other injury of unspecified body region. Ayurveda Condition: VRANAH,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Other than Classical		(1) Medicine Name: Dvija Heal+, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: -
2	Comparator Arm (Non Ayurveda)		-	Framycetin cream	To be applied in sufficient quantity on wounds twice daily for 21 days or till the complete healing of cuts and wounds (whichever is earlier)
3	Comparator Arm	Drug	Classical		(1) Medicine Name: Jatyadi Tel, Reference: Bhaishajya Ratnavali, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: -

Inclusion Criteria

Age From	18.00 Year(s)
Age To	50.00 Year(s)
Gender	Both
Details	1. Subjects who are able to understand instructions and willing to give written informed consent and comply with study protocol. 2. Subjects who agree to have their wound photographed for trial. 3. Subjects with wounds caused by trauma/ Burns (localized burns), Diabetic foot, bed sores, other co- morbid condition, post-operative wound etc. (within 7 days of occurrence) 4. Subjects with superficial and partial thickness wound. 5. Wound size of less than 49 square centimetre. 6. The subject is willing to complete all follow-up evaluations required by the study protocol

ExclusionCriteria

Details

1. Subjects having a known hypersensitivity to any of the trial medicines or their components.
2. Subjects who have received treatment (another investigational agent) within last thirty days from Screening or Baseline Visit.
3. Subjects are not willing to give informed consent.
4. Pregnant and lactating women.
5. Pediatric subjects.
6. Subjects having clinical evidence of moderate to severe bacterial or fungal infection of the wound as per visual or clinical assessment.
7. Subjects with wound requiring closure by suturing, etc. and or dressing, in the opinion of Investigator or Coinvestigator.
8. Subjects on any other conservative treatment which influences the study results.
9. Subjects with any underlying serious medical illness.
10. Immunocompromised and non- cooperative subjects and or known history of HIV AIDS.
11. Subjects with full thickness wound beyond subcutaneous layer.
12. Subjects with known immunological, hematologic disorders or metastatic malignancy.
13. Subjects having known neurological or psychiatric pathologies.
14. Subjects who have received chemotherapy or radiation therapy within the past 5 years.
15. Subject, who has used any kind of medicines local application and or oral medication for wound within 6 hours prior to Screening or Baseline Visit.
16. Subjects on NSAIDs.
17. Subjects who have received treatment with glucocorticoids for more than 10 consecutive days within 6 months prior to screening or baseline visit or oral corticosteroid with dose more than 10mg per day.
18. Subjects on systemic or topical antibiotics or systemic therapy with cytotoxic drugs.
19. Subjects having severe edema on the treatment target part.

Method of Generating Random Sequence

Permuted block randomization, fixed

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
Efficacy of the Investigational Product will be evaluated using Bates-Jensen Wound Assessment Tool (BJWAT)	Baseline, Day 2, Day 4, Day 7, Day 10, Day 14, Day 17 and Day 21 or the Day of complete healing of wound (whichever is earlier).

Secondary Outcome

Outcome	TimePoints
1. Surface area of wound 2. Different parameters of wound assessment as components of Bates-Jensen Wound Assessment Tool (BJWAT) 3. Visual assessment scale (VAS)	Baseline, Day 2, Day 4, Day 7, Day 10, Day 14, Day 17 and Day 21 or the Day of complete healing of wound (whichever is earlier).

Target Sample Size

Total Sample Size="90"
Sample Size from India="90"
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

Phase 2/ Phase 3

Date of First Enrollment (India)

22/02/2024

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="1"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Open to Recruitment

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

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

Response - NO

Brief Summary

Wound healing is a critical aspect of medical care, and the exploration of effective therapeutic interventions remains a significant area of research. Among the various approaches, polyherbal medicines have gained attention for their potential in promoting wound healing. Dvija Heal+, a polyherbal medicine, is one such formulation that has shown promise in clinical settings. The need to thoroughly study its wound healing effects arises from the increasing demand for alternative and complementary treatments. Additionally, the efficacy of traditional wound care formulations, such as framycetin cream and Jatyadi tail, has been acknowledged, prompting further investigation into their mechanisms and outcomes. This study aims to contribute to the existing body of knowledge by comprehensively assessing the wound healing properties of Dvija Heal+ and comparing its effectiveness with framycetin cream and Jatyadi tail. Such a comparative analysis is crucial for clinicians and researchers seeking evidence-based recommendations for optimal wound care, potentially leading to advancements in therapeutic strategies and improved patient outcomes.