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Treatment of diabetic wound with Ayurvedic cream

Phase 2
Completed
Conditions
Other specified diabetes mellituswith circulatory complications. Ayurveda Condition: DUSHTAVRANAH,
Registration Number
CTRI/2021/01/030502
Lead Sponsor
IPGT RA
Brief Summary

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 *Thumari*cream and Povidone-Iodine are effective in managing diabetic ulcers, with *Thumari*cream 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
100
Inclusion Criteria

1 Cases of Diabetic Wounds.

Exclusion Criteria

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1.To evaluate the wound healing effect of Thumari cream (Securinega leucopyrus) in Diabetic Wounds.4 WEEKS
2.To compare the efficacy of Thumari Ointment with Povidone-iodine ointment as the control group.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.4 WEEKS
3.To evaluate in vitro antimicrobial activity of Thumari cream (S. leucopyrus).4 WEEKS
Secondary Outcome Measures
NameTimeMethod
1.To know additional effect of Thumari cream like savarnikaran karma.2.Wound Healing time point of Thumari cream.

Trial Locations

Locations (1)

IPGT RA

🇮🇳

Jamnagar, GUJARAT, India

IPGT RA
🇮🇳Jamnagar, GUJARAT, India
Dr Pashmina Joshi
Principal investigator
9427226504
kalpashmina@gmail.com

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