Health Condition 1: null- Diabetic Foot Ulcers and Varicose Ulcers patients
Conditions
Interventions
Intervention1: 1. Millennium Panchvalakal Kwath Spray (PKS) contains Ficus bengalensis,Ficus bengalensis Ficus religiosa, Thespesia populnea,Ficus lacor
2. Healz spray (JTS) contains: Jasminum grandif
Sponsors
Millennium Herbal Care Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. 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 3. 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 (Wagenerâ??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
Exclusion criteria: 1) Patients with ischemic Ulcers (Diagnosed Clinically and/or with Doppler) 2. Known cases of Severe/Chronic Hepatic or Renal disease. 3. Known cases of any active malignancy. 4. Patients giving history of significant cardiovascular event 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 Investigatorâ??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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of change in ulcerated area (weekly till either complete ulcer healing or 3 months, whichever is ealrlier).Timepoint: 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
| Measure | Time frame |
|---|---|
| 1)Assessment of changes in ulcer 2)Assessment of changes in ulcer by Digital Photographs 3) Assessment of time required for complete healing 4)Assessment of requirement of Antibiotics, anti-inflammatory drugs 5)Assessment of adverse event by clinical evaluation, AE/SAE recording, Vitals and Lab Parameters 6)Assessment of clinical global evaluation for overall efficacy by physician and by the patient 7)Assessment of overall acceptability/tolerability by Subject and physician Timepoint: 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. | — |
Countries
India
Contacts
Public ContactVandana Bade
Target Institute of Medical Education and Research
Outcome results
None listed