Clinical study on Topical Herbal Sprays on Ulcers

Phase 2/3

Completed

• Conditions: Diabetic Foot Ulcers and Varicose Ulcers patients

• Registration Number: CTRI/2017/09/009703
• Lead Sponsor: Millennium Herbal Care Ltd

Brief Summary

It is A Randomized, Open Labeled, Multi-center, Prospective, ComparativeClinical Study to evaluate efficacy and safety of Topical Herbal Sprays on NonHealing Ulcers – Diabetic Foot Ulcers & Varicose Ulcers. The trial will becompleted in 72 patients in 4 centers across India. Subjects from group A willbe advised to clean their ulcer using Millennium Panchvalkal Kwath Spray (PKS) andthen by application of Healz Spray (JTS) followed by dressing of the ulcer for3 months of complete healing of ulcer whichever is earlier.  Subjects from group B will be advised to cleantheir ulcer using Hydrogen peroxide and/or Hypochlorite Solution and then applicationof Povidone iodine 10% (Betadine) followed by dressing of the ulcer for 3months of complete healing of ulcer whichever is earlier. The primary objective of the study isto evaluate change in ulcerated area on Day -5, Day 0, Day 7, Day 14, Day 21, Day28, Day 35, Visit Day 42, Day 49, Day 56, Day 63, Day 70, Day 77, Day 84, Day91. The secondary objectives are to evaluate changes in ulcer by ClinicalExamination, changes in ulcer by Digital Photographs, time required forcomplete healing (if ulcer heals completely, requirement of Antibiotics,anti-inflammatory drugs, adverse event by clinical evaluation, AE/SAErecording, Vitals and Lab Parameters, clinical global evaluation for overallefficacy by physician and by the patient and overall acceptability/tolerabilityby Subject and physician on Day -5, Day 0, Day 7, Day 14, Day 21, Day 28, Day35, Visit Day 42, Day 49, Day 56, Day 63, Day 70, Day 77, Day 84, Day 91.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-27
• Last Update Posted: 2020-09-06

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Patients having either Type I or Type II Diabetes with non-healing Diabetic Foot Ulcers or patients having non-healing Varicose Ulcers with or without Diabetes 2.
• Diabetic patients having HbA1C < 8.
• Patients having either Diabetic Foot Ulcer or Varicose Ulcers with the following Ulcer characteristics : a.
• Neuropathic and mild Neuro-ischaemic Diabetic Foot Ulcer (Single or multiple ulcers) b.
• Diabetic Foot ulcers with Grade 1 to 2 (Wagener’s classification)(Appendix B) c.
• Non-Healing Varicose Ulcers d.
• Duration of ulcer more than 1 month e.
• Surface area of the Non-Healing Ulcer between 1 cm2 to 25 cm2 5.
• Patients willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form.

Exclusion Criteria

• 1. Patients with ischemic Ulcers (Diagnosed Clinically and/or with Doppler) 2.
• Known cases of Severe/Chronic Hepatic or Renal disease.
• Known cases of any active malignancy.
• Patients giving history of significant cardiovascular event < 12 weeks prior to randomization.
• 5. Chronic alcoholics / Alcohol Abuse.
• 6. Patients ECG demonstrating any signs of uncontrolled arrhythmia / acute ischemia.
• 7. Patients X- ray chest showing any active lesion of tuberculosis.
• 8. Patients having known chronic, contagious infectious disease, such as active tuberculosis Hepatitis B or C, or HIV.
• 9)Patients using any other investigational drug within 1 month prior to recruitment.
• 10. Known hypersensitivity to any of the ingredients used in study drug.
• 11. Pregnant and Lactating females.
• 12. Patients currently participating in any other Clinical study or any education treatment program for Ulcers.
• 13. Patients having any other medical or surgical condition considered unsuitable for his/her participation in the study as per Investigator’s judgment.
• 14. Patients receiving drugs which may interact with the study therapeutic protocol such as glucocorticoids, immunosuppressive and cytotoxic drugs.
• 15. Patients who have undergone ulcer treatments with cell therapy, dermal substitutes, or other biological therapies within the last 30 days.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of change in ulcerated area (weekly till either complete ulcer healing or 3 months, whichever is ealrlier).	Day -5, Day 0, Day 7, Day 14, Day 21, Day 28, Day 35, Visit Day 42, Day 49, Day 56, Day 63, Day 70, Day 77, Day 84, Day 91

Secondary Outcome Measures

Name	Time	Method
1)Assessment of changes in ulcer	2)Assessment of changes in ulcer by Digital Photographs 3) Assessment of time required for complete healing

Trial Locations

Locations (6)

Ayurved Seva Sangh, Ayurved Sanshodhan Vibhag, Ganeshwadi, Panchvati, Nasik; 🇮🇳 Nashik, MAHARASHTRA, India

Government Ayurvedic College Solapur Road Madhuban Osmanabad; 🇮🇳 Osmanabad, MAHARASHTRA, India

Govt. Ayurved College Vazirabad, Nanded; 🇮🇳 Nanded, MAHARASHTRA, India

MAMs SS Ayurveda Mahavidyalaya and Sane Guruji Arogya Kendra Malwadi Hadapsar Pune; 🇮🇳 Pune, MAHARASHTRA, India

R A Podar Medical College(Ayu) M.A.Podar Hospital Worli, Mumbai; 🇮🇳 Mumbai, MAHARASHTRA, India

S.D.M. College of Ayurveda, Kuthpady,Udupi; 🇮🇳 Udupi, KARNATAKA, India

Ayurved Seva Sangh, Ayurved Sanshodhan Vibhag, Ganeshwadi, Panchvati, Nasik

🇮🇳Nashik, MAHARASHTRA, India

Dr Santosh S Pathak

Principal investigator

9405369727

drsantoshsp@gmail.com