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Scientific study in humans to assess wound healing efficacy of Thumari nanoemulgel and Thumari kalka in diabetic foot ulcer

Wound Healing Efficacy of Thumari Nanoemulgel and Thumari Kalka in Diabetic Foot Ulcer: A Multi-Arm, Randomized Controlled Clinical Trial - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/05/087173
Enrollment
90
Registered
2025-05-20
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

Health Condition 1: E086- Diabetes mellitus due to underlying condition with other specified complications

Interventions

None listed

Sponsors

Institute of teaching and Research in Ayurveda
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Diabetic foot ulcers of Grade 1 and 2 of Wagner s classification Ulcer area more than 0.5cm2

Exclusion criteria

Exclusion criteria: Venous ulcer, malignant wound, tuberculous wound, leprosy ulcer, syphilitic ulcers. Severe peripheral arterial disease- ischemic pain at rest ABI less than or equal to 0.4 Pregnancy and breastfeeding women. Any kind of malignancy of other organs. Uncontrolled Hypertension and diabetes HbA1C more than 8 Heart diseases like Myocardial infarction, coronary artery disease, and ischemic heart disease. Positive cases of HIV, HBsAg, HCV.

Design outcomes

Primary

MeasureTime frame
Complete healing of the ulcer with no visible wound. Time taken for complete healing (epithelialization) of ulcer. Percentage reduction in wound area. Timepoint: Day 0, 7,14,21,28,35 42

Secondary

MeasureTime frame
Standard manufacturing process of Thumari nanoemulgel. In-vitro anti-microbial action of Thumari nanoemulgel. Effect of Thumari nanoemulgel on growth factors. Effect of groupwise treatment on presence of microbes (bacterial or fungal) found with swab culture diagnostic method. Quality of life Timepoint: Follow up on Day 7,14,21,28,35,42

Countries

India

Contacts

Public ContactSupriya Vivek Singh

Institute of Teaching and Research in Ayurveda

drsupriyakurane123@gmail.com8419998961

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026