CTRI/2025/09/094146 [Registered on: 03/09/2025] Trial Registered Prospectively
Last Modified On:
03/09/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Ayurveda
Study Design
Randomized, Parallel Group Trial
Public Title of Study
RCT of Nivarana FastAid oil® in chronic and nonhealing ulcers
Scientific Title of Study
Randomized Controlled Trial to evaluate the efficacy and safety of Nivarana FastAid oil® in the management of chronic and non healing ulcers
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Arunkumar Radhakrishnan
Designation
Vice Principal, Professor and Head, Department of Pharmacology
Affiliation
Chettinad Hospital and Research Institute
Address
Department of Pharmacology,
Chettinad Hospital ad Research Institute,
Chettinad Academy of Research and Education,
Rajiv Gandhi Salai, OMR road, Kelambakkam, Chennai
Chennai TAMIL NADU 603103 India
Phone
9094752000
Fax
Email
arunkumarr@care.edu.in
Details of Contact Person Scientific Query
Name
Arunkumar Radhakrishnan
Designation
Vice Principal, Professor and Head, Department of Pharmacology
Affiliation
Chettinad Hospital and Research Institute
Address
Department of Pharmacology,
Chettinad Hospital ad Research Institute,
Chettinad Academy of Research and Education,
Rajiv Gandhi Salai, OMR road, Kelambakkam, Chennai
Chennai TAMIL NADU 603103 India
Phone
9094752000
Fax
Email
arunkumarr@care.edu.in
Details of Contact Person Public Query
Name
Arunkumar Radhakrishnan
Designation
Vice Principal, Professor and Head, Department of Pharmacology
Affiliation
Chettinad Hospital and Research Institute
Address
Department of Pharmacology,
Chettinad Hospital ad Research Institute,
Chettinad Academy of Research and Education,
Rajiv Gandhi Salai, OMR road, Kelambakkam, Chennai
Chennai TAMIL NADU 603103 India
Phone
9094752000
Fax
Email
arunkumarr@care.edu.in
Source of Monetary or Material Support
Chettinad Hospital ad Research Institute,
Chettinad Academy of Research and Education,
Rajiv Gandhi Salai, OMR road, Kelambakkam, Chennai
OzoNiv Pvt Ltd.
Primary Sponsor
Name
OzoNiv Pvt Ltd
Address
1st Floor, No 215, New tiny Shed, Industrial Estate, Ambattur, Chennai 600058
Type of Sponsor
Pharmaceutical industry-Indian
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 Arunkumar Radhakrishnan
Chettinad Hospital and Research Institute
Chettinad Academy of Research and Education,
Rajiv Gandhi Salai, OMR road, Kelambakkam, Chennai 603103 Chennai TAMIL NADU
9094752000
arunkumarr@care.edu.in
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
CARE - IHEC for Faculty Research
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition:L899||Pressure ulcer of unspecified site. Ayurveda Condition: VRANAH, (2) ICD-10 Condition:I830||Varicose veins of lower extremities with ulcer. Ayurveda Condition: VRANAH, (3) ICD-10 Condition:E116||Type 2 diabetes mellitus with other specified complications. Ayurveda Condition: VRANAH,
All routine treatment including surgical intervention,
antibiotics, other medications, wound care, topical application, if any and dressing.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
80.00 Year(s)
Gender
Both
Details
1. Participants between 18 and 80 years (both years inclusive), all genders who consent to participate in the study and willing to comply with the protocol requirements.
2. Females of childbearing potential – Negative urine pregnancy test and not breastfeeding and willing to avoid pregnancy during the study period by adopting acceptable method of contraception, such as hormonal methods (pills, patches, injections, implants, vaginal rings), barrier methods (condoms, diaphragms, cervical caps), intrauterine contraceptive devices (IUCDs), and sterilization.
3. Size of the ulcer – Ranging from 0.5 cm2 to 25 cm2
4. Duration of ulcer - 3 weeks and more
5. Normal or clinically insignificant deviations of complete blood count, renal function tests and liver function tests
6. Haemoglobin level to be 10g/dl or more for females and 12g/dl or more for males and other genders
7. Ankle Brachial Pressure Index(ABPI) - 0.8 to 1.2.
8. Participants - with or without diabetes mellitus or hypertension or peripheral neuropathy
9. The comorbid conditions should be stable and controlled in view of the investigator
10. Ulcer must be of any one of the three types– diabetic ulcer or venous ulcer or pressure ulcer
o In case of diabetic ulcer - Grade 1 or 2 of Wagner’s classification and the participants must be diabetic &HbA1c lesser than and equal to 12 percent
o In case of venous ulcer - Doppler study showing venous insufficiency and HbA1c less than 9 percent in case of diabetics
o In case of Pressure ulcer - Stage II and III as per the National Pressure Ulcer Advisory Panel (2007) classification and HbA1c less than 9 percent in case of diabetics
ExclusionCriteria
Details
1. History of hypersensitivity to the study medication(s)
2. Ulcers having mixed etiologies
3. Ulcers with significant cellulitis and/or infection and/or gangrenous features in view of the investigator
4. Ulcers with osteomyelitis and/or exposed bone
5. Histopathology of ulcer showing malignancy
6. Participants with significant and unstable / uncontrolled / severe systemic disorders like cardiovascular, CNS, psychiatry, respiratory, gastrointestinal and renal diseases
o Comorbid conditions related to the three types of ulcers included in the study such as diabetes mellitus, venous insufficiency and conditions leading to pressure sores are not excluded
7. Participants with tuberculosis, leprosy, lymphedema, deep venous thrombosis and other pathologies that can result in chronic and non – healing ulcers
8. Participants with systemic sepsis
9. Concomitant medications other than what is required to treat diabetes and/or venous insufficiency and/or pressure ulcer and/or standard of care
10. Any other comorbid conditions that may affect the participants’ safety in view of the investigator
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
Reduction in the wound size, antimicrobial activity and changes in the histopathological examination.
Baseline (0), weekly follow-up for 12 weeks
Secondary Outcome
Outcome
TimePoints
Local and systemic adverse events.
Weekly follow - up for 12 weeks
Target Sample Size
Total Sample Size="60" Sample Size from India="60" 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
Post Marketing Surveillance
Date of First Enrollment (India)
01/10/2025
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 Yet Recruiting
Recruitment Status of Trial (India)
Not Yet Recruiting
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
Chronic and non- healing ulcers cause pain, decreased mobility, increased exudates and a limited social life, compromising a person’s health and well-being. This leads to significant disruption, morbidity, and indirect costs to the healthcare and social systems. There has been extensive research in Ayurveda focused on promoting wound healing. The Government of India encourages the conduct of clinical trials to generate evidence for the safety and efficacy of the herbal formulations. These ulcers often resist standard treatments, requiring a more comprehensive approach. Evidence suggests that Nivarana FastAid oil®has strong antimicrobial and anti-inflammatory properties. This makes it beneficial in treating chronic and non – healing ulcers, by minimizing infection and inflammation and accelerating tissue regeneration. Therefore, we wanted to conduct this randomized controlled clinical trial to investigate the efficacy and safety of NivaranaFastAid oil in chronic and non – healing ulcers.
It is a Single centre, Open labelled, Randomized controlled clinical trial.
Study treatments:
Test (T): Standard of care + NivaranaFastAid oil®
Control (C): Standard of care – All routine treatment including surgical intervention, antibiotics, other medications, wound care, topical application, if any and dressing.
Treatment duration: 12 weeks, from randomization to end of study
No. of study participants: Total – 60 patients
Diabetic ulcer
30,1:1 randomization
Venous ulcer
20,1:1 randomization
Pressure ulcer
10,1:1 randomization
Study procedure:
All the potential participants will undergo a screening procedure (visit 0) after obtaining written informed consent, which includes
i) Clinical screening - demographic information, vital parameters, clinical examination, monofilament test for peripheral neuropathy, ABPI
ii) Diagnostic screening – Complete blood count (CBC), Renal function test (RFT), Liver function test (LFT), Doppler scan, Fasting blood sugar, Postprandial blood sugar and HbA1c.
iii) Wound examination as follows –
·Wound characteristics: physical examination[location, warmth, pain, odour], evidence of infection[erythema, pain, swelling, fluctuance, purulence, and loss of function], surface area[depth, length, and width of the wound], type of tissue[granulation, fibrinous, eschar], wound bed[exposed bones and vessels], exudates[presence, type and amount], wound margins [tunneling, rolled edges, undermining, and fibrotic changes]
·Wound swab for culture and sensitivity
·Histopathological examination.
In the subsequent visit (visit 1 - which will be within 5 days of visit 0), the participants who fulfil the inclusion and exclusion criteria will be enrolled in the study. The participants will be allocated to any one of the treatment arms (T/C) based on randomization. After enrolment in the study, all the participants will receive standard of care as mentioned above and in addition, participants in Test group alone will receive NivaranaFastAid oil® for the duration of 12 weeks.
During visit 1, the investigator will provide wound care including standard of care with or without application of NivaranaFastAid oil® based on randomization. Thereafter the participants will visit the hospital every week (visit 2 to visit 12) during which the investigator will provide wound care based on randomization. In between two successive visits, the participants will do self-care or can visit the hospital for the wound care based on the need and convenience. If the participants have multiple ulcers, the largest ulcer will be taken into consideration for evaluating the treatment efficacy, though treatment will be offered for all the wounds.
In this study, Nivarana FastAid oil® will be applied every day starting from visit 1 to end of study (visit12) in the group which is randomized to receive “T” treatment. The other group will receive daily wound care as per standard of care.
During every visit (visit 1 to 12) the following data will be collected from the participants.
ii) Monthly - Fasting blood sugar and Postprandial blood sugar
iii) 12th week (end of study) – Wound swab for culture and sensitivity (In case if the wound is not fully healed), Wound biopsy for histopathological examination (if applicable in case of wounds not completely healed), Complete blood count (CBC), Renal function test (RFT), Liver function test (LFT), Fasting blood sugar, Postprandial blood sugar and HbA1c.
*Renal function test – Urea, Creatinine, Uric acid; Liver function tests: SGOT, SGPT, ALP, GGT, S.Bilirubin