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PROTOCOL
Year : 2022  |  Volume : 6  |  Issue : 3  |  Page : 142-147

Efficacy of the topical application of C1 herbal oil on superficial external wounds and split thickness skin graft donor sites for wound healing: A study protocol for prospective, randomized, controlled, two-phased clinical trial


1 Department of Plastic surgery Burns and Plastic Surgery, All India Institute of Medical Sciences (AIIMS), Janakpuri, New Delhi, India
2 Central Council for Research in Ayurvedic Sciences (CCRAS), Janakpuri, New Delhi, India

Correspondence Address:
Dr. Shruti Khanduri
Central Council for Research in Ayurvedic Sciences (CCRAS), Janakpuri, New Delhi
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jras.jras_88_22

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BACKGROUND: C1 herbal oil is developed by Central Council for Research in Ayurvedic Sciences, Ministry of Ayush, Government of India and is based on Local Health traditions (LHTs) for wound healing. This study is planned to assess the efficacy of C1 herbal oil on Superficial External Wounds and Split Thickness Skin Graft (STSG) donor sites for wound healing. MATERIALS AND METHODS: The study is a prospective, open-label, randomized, controlled, two-phased clinical trial for a duration of 28 days. Outpatients of age group 18–60 years, of either sex requiring STSG coverage of at least two strips will be recruited in Phase 1 of the study. The donor site will receive the topical application of C1 herbal oil prior to the standard dressing, whereas the normal saline will be applied on the control site. The dressings will not be changed, except when it is fully soaked with exudates or will easily fall off or show any signs of infection. Subjects with superficial external wounds will be recruited in Phase 2 of the study. The test site will receive C1 herbal oil-impregnated dressings, whereas the other group will receive saline gauze dressing, to be changed every 24 h or earlier in case of soakage or accidental removal. The duration of wound healing was the primary outcome measure. The pain during dressing change will be evaluated with a visual analog scale and wound assessment by Bates Jensen Wound Assessment Tool. DISCUSSION: Ayurveda herbal wound dressing may significantly reduce the time for epithelialization of wounds. It may be beneficial in decreasing healthcare costs besides including Ayurveda medicines in mainstream clinical medicine for wound care. TRIAL REGISTRATION: Clinical trials registry- India: CTRI/2017/10/010150


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