Healing effect of thumari taila and apamarga Kshara taila in Diabetic ulcers management

Phase 3

Completed

• Conditions: Non-pressure chronic ulcer of unspecified part of lower leg,

• Registration Number: CTRI/2019/02/017729
• Lead Sponsor: Institute for Post graduate teaching and research in Ayurveda

Brief Summary

The research studyentitled “A comparative clinical assessment of healing effect of *ApamargaKshara Taila* and *Thumari Taila* in the management of Diabetic ulcer.â€was aimed to evaluate and compare diabetic wound healing effect of *ApamargaKshara Taila* and *Thumari Taila.* Another Objective was to evaluate invitro antimicrobial effect of both the oils. This trialwas summarized in review of literature, including Ayurvedic literature andmodern literature of Wound andDiabetic Ulcer.

**Drug review** comprises classical narration of both medicaments of both the groups. Theyare: *Thumari Taila* (*Scurinega* *leucopyrus* Willd. &Meull)*, Apamarga Kshara Taila (Achyrenthus aspera* Linn*.), Pippali(Piper longum* Linn.), *Haritaki* (*Terminalia chebula* Retz.), *TriphalaKwatha* (Decoction of three herbs like, *Terminalia bellirica* Roxb., *Terminaliachebula* Retz. and (*Embellica officinalis* Linn.) and *SanjivaniVati* (A herbo mineral preparation). Also, it comprises formulation of boththe oils i.e., *Thumari Taila* and *Apamarga Kshara Taila,* their pharmaceuticaland analytical analysis and microbiological stability study.

**In- vitro antimicrobial study** consists report of Antibacterial activityof both the oils against *S. aureus, E. coli*, *Pseudomonas aeruginosa*and *Klebsiella pneumonie* in compare to ampicillin. *Thumari Taila*was reported having anti-bacterial effect against S. aureus. Antifungal assayof both the oils was carried out against *Candida albicans, Candida glabrata,Aspergillus* and *Candida tropicalis* in compare to fluconazole. *ThumariTaila* with dry drug sample was found having anti-fungal activity against *Candidaalbicans, Candida glabrata* and *Candida tropicalis.*

**Clinical Study** stats the open label comparative clinical study of80 clinical cases of diabetic ulcer. On the basis of computer-generated randomnumber table, Group A (n=41) cases were treated by applying study drug *ApmargaKshara Taila* and Group B (n=39) cases were treated by applying *ThumariTaila* in diabetic ulcer for 30 days. In both groups, adjuvant drugs like *Triphala Kwatha* (for local woundcleaning just prior to wound dressing), *Pippali Choorna* (*Piper longum*Linn.) (3gm empty stomach with water)*, Haritaki Choorna* (powder of *Terminaliachebula* Retz.) (6 gm at bed time with Luke warm water) and *SanjivaniVati* (125mg each) (four times a day) were given commonly in same dose andduration. All the cases were screened for essential serology, hematology,urology, bio-chemical and radiological investigations prior their enrollmentfor the study.  The effect of the treatment was assessed onthe basis of relief in subjective parameters (odor, peri-wound skin, dischargeand pain) and objective parameters i.e., wound size and clinical microbiology.All the cases were followed up for 1 month. The observed results in the studywere subjected to statistical calculation to derive final conclusion.

**Discussion**ofthe study was made on all demographic observations, clinical findings andinvitro antimicrobial study.  Conclusionof clinical study suggested that both the groups medicaments have shown highlysignificant effect in healing ofdiabetic ulcers. *Apamarga Kshara Taila* has been proven as good as *ThumariTaila* in relieving subjective criteria like *Gandha* (odor), *Varna* (peri-woundskin), *Srava* (discharge), *Vedana* (pain) and *Akriti* (woundsize). Both the medicines were also found effective in reducing microbial loadof the ulcers and improving unit healing time. From this clinical study,it was concluded that, *Apamarga Kshara Taila and Thumari Taila* have equalwound healing effect in the management of diabetic ulcers. Hence alternatehypothesis (H1) is rejected and null hypothesis (H0) isaccepted i.e., there is no difference between healing effects of *ApamargaKshara Taila and Thumari Taila* in the management of Diabetic ulcers.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-28
• Study Completion: 2020-09-19
• Last Update Posted: 2021-01-23

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• •Diagnosed Cases of diabetic ulcer/ulcers •Patients of age group of 30.
• 70 years of either sex.

Exclusion Criteria

• 1.Malignant ulcers, tubercular ulcers, leprotic ulcers, syphilitic ulcers 2.
• Past history of Tuberculosis 3.Patients of Malignancy of any organ 4.Uncontrolled Hypertension.
• •Heart diseases like MI, CAD, IHD •Patients with HIV, HBsAg, HCV.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Healing of diabetic ulcers	2 years

Secondary Outcome Measures

Name	Time	Method
PREVENTION FROM AMPUTATION	2 years

Trial Locations

Locations (1)

PG AYURVED HOSPITAL IPGT AND RA; 🇮🇳 Jamnagar, GUJARAT, India

PG AYURVED HOSPITAL IPGT AND RA

🇮🇳Jamnagar, GUJARAT, India

FORAM JOSHI

Principal investigator

9924468211

dr.foramj@gmail.com