A Clinical Study to Evaluate the Efficacy of a Combination of Internal Medicines and Local Treatment in Chronic Non-Healing Wounds

Evaluation of the Efficacy of Guduchi Triphaladi Guggulu and Gandharv Haritaki as Internal Medication along with Vrana Dhavan by Nimba Patra Kashay and Local application of Nimbadi Ointment in Chronic Non-Healing Wound- A Randomised Control Trial - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/04/066064

Enrollment

Registered

2024-04-22

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L984- Non-pressure chronic ulcer of skin, not elsewhere classified

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1) Patients of the age group 19-70 years having Chronic Non-Healing wound (Wound which is not healed by 40-50% after 4 weeks of standard treatment) of any of the following types- - Venous Ulcers - Diabetic Ulcers - Trophic Ulcers - Burns ICD Code- ICD-10 code 2024 ICD-10-CM Diagnosis Code L98.499 Non-pressure chronic ulcer of skin of other sites with unspecified severity will be followed. Following synonyms from ICD will be excluded- 1. Chronic ulcer of Left ear 2. Chronic Ulcer of Right ear 3. Diabetes Type 1 with Chronic Skin Ulcer 4. Diabetes Type 1 with Diabetic skin Ulcer

Exclusion criteria

Exclusion criteria: 1) Patients with WBC count above 12000/mm3 2) Immunocompromised patients like HIV, HbsAg, HCV positive patients 3) Pressure sores 4) Known cases of TB, Leprosy ulcer, Malignant Ulcers 5) Pregnant females 6) Uncontrolled Diabetes, Hypertension. 7) Hepatic and Renal Failure

Design outcomes

Primary

Measure	Time frame
More than 50 % healing of the chronic non healing wound.Timepoint: 28th day	—

Secondary

Measure	Time frame
Digital Image of WoundTimepoint: Day 0, Day 14, Day 28;Growth Factor – VEGF-A using ELISA MethodTimepoint: Day 0, Day 14, Day 28;Histopathological Analysis of by Edge BiopsyTimepoint: Day 0, Day 14, Day 28;Hydroxyproline assay- ELISA methodTimepoint: Day 0, Day 14, Day 28;Wound Swab CultureTimepoint: Day 0, Day 14, Day 28	—

Countries

India

Contacts

Public ContactDr V D Mahanta

ALL INDIA INSTITUTE OF AYURVEDA, NEW DELHI

dryogesh.badwe@gmail.com9011060498

Outcome results