Study to Check if Sakriyam Oil is Safe for Healing Cuts

An Open-Label, Single-Arm, Single-Center Clinical Study to Evaluate the Safety and Efficacy of Sakriyam Oil in the Management of Open Wound Injuries. - NIL

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/10/096709

Enrollment

Registered

2025-10-31

Start date

Unknown

Completion date

Unknown

Last updated

2025-11-17

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

Conditions

Health Condition 1: T14- Injury of unspecified body region

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or female adults between 18 and 65 years of age. 2. Having mild-to-moderate open wound(s) less than 72 hours old at the time of screening. 3. Able and willing to provide written informed consent. 4. Women of childbearing potential must be willing to practice an acceptable method of contraception for the duration of the study. 5. Willingness and ability to comply with all study procedures, visit schedules, and follow-up assessments.

Exclusion criteria

Exclusion criteria: 1. Pregnant, breastfeeding, or planning pregnancy during the study. 2. Deep or complicated wounds with exposed bone or muscle. 3. Presence of diabetic ulcers, infected wounds, or gangrenous tissue. 4. Participation in any other interventional clinical trial within the past 30 days. 5. Known hypersensitivity or allergy to any constituent of Sakriyam Oil. 6. Any significant concurrent illness or condition that, in the opinion of the Investigator, may interfere with study participation, safety, or data interpretation.

Design outcomes

Primary

Measure	Time frame
1. Absolute and percentage change in wound length (cm) from Baseline to Day 7 and Day 15. 2. Absolute and percentage change in wound width (cm) from Baseline to Day 7 and Day 15. 3. High-definition (HD) imaging–based assessment of wound healing at Day 15 compared to Baseline, documenting epithelialization and granulation tissue formation.Timepoint: Screening & Baseline (Day 0), Follow-up (Day 7 ±2), End of Study (Day 15 ±2)	—

Measure

Time frame

1. Absolute and percentage change in wound length (cm) from Baseline to Day 7 and Day 15. 2. Absolute and percentage change in wound width (cm) from Baseline to Day 7 and Day 15. 3. High-definition (HD) imaging–based assessment of wound healing at Day 15 compared to Baseline, documenting epithelialization and granulation tissue formation.Timepoint: Screening & Baseline (Day 0), Follow-up (Day 7 ±2), End of Study (Day 15 ±2)

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Secondary

Measure	Time frame
hange in Subject Global Assessment (SGA) scores for redness, pus formation, swelling, pain, and itching from baseline to Day 7 and Day 15. Change in Visual Analogue Scale (VAS) scores for pain and itching from baseline to Day 7 and Day 15. Change in health-related quality of life scores as measured by the EQ-5D-5L questionnaire from baseline to Day 15. Safety and tolerability endpoints, including: Incidence and severity of adverse events. Local tolerability outcomes such as erythema, dermatitis, or signs of infection. Any serious adverse events recorded throughout the study period.Timepoint: Screening & Baseline (Day 0), Follow-up (Day 7 ±2), End of Study (Day 15 ±2)	—

Measure

Time frame

hange in Subject Global Assessment (SGA) scores for redness, pus formation, swelling, pain, and itching from baseline to Day 7 and Day 15. Change in Visual Analogue Scale (VAS) scores for pain and itching from baseline to Day 7 and Day 15. Change in health-related quality of life scores as measured by the EQ-5D-5L questionnaire from baseline to Day 15. Safety and tolerability endpoints, including: Incidence and severity of adverse events. Local tolerability outcomes such as erythema, dermatitis, or signs of infection. Any serious adverse events recorded throughout the study period.Timepoint: Screening & Baseline (Day 0), Follow-up (Day 7 ±2), End of Study (Day 15 ±2)

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Countries

India

Contacts

Public ContactMs Arpita Malgi

Samahitha Research Solutions

satyalm@samahitha.com09739001749

Outcome results