跳至主要内容
临床试验/CTRI/2021/01/030502
CTRI/2021/01/030502已完成2 期

A Clinical Study of Thumari (Securinega leucopyrus) cream and Povidone of Iodine in the Management of MADHUMEHJANYA VRANA (w.s.r. to Diabetic Wound)- A Randomised Standard Controlled Trial

IPGT RA1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年10月2日最近更新:

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
1.To evaluate the wound healing effect of Thumari cream (Securinega leucopyrus) in Diabetic Wounds.

研究概览

简要总结

This randomized controlled trialinvestigates the efficacy of Thumari (Securinega leucopyrus) creamcompared to Povidone-Iodine in the management of diabetic ulcers (Madhumehajanya**Vrana). The study aimed to evaluate the wound healing properties,microbial control, and overall therapeutic effect of these topical treatmentsin diabetic patients with non-healing wounds.

A total of 141 patients withdiabetic ulcers were screened, and 106 were included in the study. 96 patientswere randomly divided into two groups: Group A-Treated group n=45 (Thumari cream)and Group B-control group n=51 (Povidone-Iodine). Both groups were treated withthe respective topical agents, and the outcomes were evaluated based on subjectivesymptoms (pain, odour, itching, signs of infection), objective parameters(wound size), and laboratory investigations (microbial load, fasting bloodsugar levels).

The results revealed that Thumari cream significantlyreduced pain (89.5%), odour (94.7%), and signs of infection (92.6%) compared toPovidone-Iodine, which showed relief in pain (73.7%) and odour (74.6%) but to alesser extent. Both topical applications demonstrated a significant reductionin wound size, with Thumari cream showing an 84.8% improvement comparedto 52.4% with Povidone-Iodine. Moreover, Thumari cream exhibited agreater reduction in microbial load and fasting blood sugar levels thanPovidone-Iodine, although no significant difference was noted in the microbialload reduction between the two groups.

The study concluded that both Thumaricream and Povidone-Iodine are effective in managing diabetic ulcers, with Thumaricream showing superior effects in wound healing and microbial control. Bothagents were found to be safe, with no adverse drug reactions reported as local application.The study also emphasizes the potential of integrating Ayurvedic treatmentslike Thumari cream with modern wound care practices. Further researchwith larger sample sizes, longer treatment durations, and additional studies onthe biological mechanisms of Thumari cream is recommended.

Keywords:

Ayurvedictreatment, Diabetic foot ulcer, Diabetic ulcers, Madhumeha, Madhumehajanya Vrana,Microbial load, Povidone-Iodine, Randomized controlled trial, Securinega leucopyrus,Thumari cream, Wound healing, Wound management.

研究设计

研究类型
Interventional
分配方式
Random Number Table
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • 1 Cases of Diabetic Wounds.

排除标准

  • 1 Malignant ulcers, tubercular ulcers, leprosy ulcers 2 Past history of Tuberculosis 3 Patients of Malignancy of any organ 4 Uncontrolled Hypertension 5 Heart diseases like MI, CAD, IHD 6 Patients with AIDS & STD 7 Patients with uncontrollable DM and Septicemia.

结局指标

主要结局

1.To evaluate the wound healing effect of Thumari cream (Securinega leucopyrus) in Diabetic Wounds.

时间窗: 4 WEEKS

2.To compare the efficacy of Thumari Ointment with Povidone-iodine ointment as the control group.

时间窗: 4 WEEKS

4. Wound healing will be assessed by measuring the size of the wound (length x Width) and relief of signs and symptoms of the morbidity of diabetic wound.

时间窗: 4 WEEKS

3.To evaluate in vitro antimicrobial activity of Thumari cream (S. leucopyrus).

时间窗: 4 WEEKS

次要结局

  • 1.To know additional effect of Thumari cream like savarnikaran karma.(2.Wound Healing time point of Thumari cream.)

研究者

发起方
IPGT RA
申办方类型
Research institution and hospital

研究点 (1)

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