| CTRI Number |
CTRI/2025/07/091897 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
28/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
AN OPEN LABEL RANDOMISED CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF ACHYRANTHES ASPERA MEDICATED GAUZE WITH CALOTROPIS GIGANTEA MEDICATED GAUZE IN THE MANAGEMENT OF DIABETIC FOOT ULCER. |
|
Scientific Title of Study
|
AN OPEN LABEL RANDOMISED CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF APAMARGA KSHARAPLOTA WITH SHWETA ARKA KSHARAPLOTA IN THE MANAGEMENT OF KAPHAJA DUSHTA VRANA Vis-a-vis DIABETIC FOOT ULCER. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr SUSHMITHA M R |
| Designation |
2nd YEAR PG SCHOLAR |
| Affiliation |
JSS AYURVEDA MEDICAL COLLEGE AND HOSPITAL MYSURU |
| Address |
JSS AYURVEDA MEDICAL COLLEGE &
HOSPITAL LALITHADRIPURA ROAD
MYSURU
JSS AYURVEDA MEDICAL COLLEGE &
HOSPITAL LALITHADRIPURA ROAD
MYSURU
Mysore KARNATAKA 570028 India |
| Phone |
9620207535 |
| Fax |
|
| Email |
sushmithamr06022000@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Siddayya Aradhyamath |
| Designation |
Professor and HOD |
| Affiliation |
JSS AYURVEDA MEDICAL COLLEGE AND HOSPITAL MYSURU |
| Address |
JSS AYURVEDA MEDICAL COLLEGE &
HOSPITAL LALITHADRIPURA ROAD
MYSURU, 570028
JSS AYURVEDA MEDICAL COLLEGE &
HOSPITAL LALITHADRIPURA ROAD
MYSURU, 570028 Mysore KARNATAKA 570028 India |
| Phone |
9449972788 |
| Fax |
|
| Email |
dr.siddesharadyamath@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Siddayya Aradhyamath |
| Designation |
Professor and HOD |
| Affiliation |
JSS AYURVEDA MEDICAL COLLEGE AND HOSPITAL MYSURU |
| Address |
JSS AYURVEDA MEDICAL COLLEGE &
HOSPITAL LALITHADRIPURA ROAD
MYSURU, 570028
JSS AYURVEDA MEDICAL COLLEGE &
HOSPITAL LALITHADRIPURA ROAD
MYSURU, 570028
Mysore KARNATAKA 570028 India |
| Phone |
9449972788 |
| Fax |
|
| Email |
dr.siddesharadyamath@gmail.com |
|
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Source of Monetary or Material Support
|
| JSS Ayurveda medical college and hospital, # 41/ E, Lalithadripura Road, Alanahalli, Mysuru- 570023 |
|
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Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sushmitha M R |
JSS Ayurveda medical college and hospital |
Room No.10 Department Of PG And Ph.D Studies In Shalya Tantra
JSS Ayurveda Medical College and Hospital,#41/E, Lalithadripura,
Mysuru- 570028
Mysore
KARNATAKA
570028
India Mysore KARNATAKA |
9620207535
sushmithamr06022000@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JSS AYURVEDA MEDICAL COLLEGE MYSURU |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E115||Type 2 diabetes mellitus with circulatory complications. Ayurveda Condition: DUSHTAVRANAH, |
|
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Intervention / Comparator Agent
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| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | kShArakarma, क्षारकर्म | (Procedure Reference: Susrutha samhitha, Procedure details: The gauze piece of size 23cm in diameter will be fixed to double layered circular wooden ring.
On first coating Snuhi Ksheera( 50ml) will be smeared on gauze piece and kept in the UV Ksharasutra cabinet and dried.
On second coating Snuhi Ksheera( 50ml) will be smeared over the gauze piece followed by Apamarga Kshara ( 20gram) application and kept in the UV Ksharasutra cabinet and dried.
On third coating Snuhi Ksheera will be smeared followed by Haridra choorna ( 20gram) application and kept in the UV Ksharasutra cabinet and dried.
Stored in sterile polythene bag.
) (1) Medicine Name: Apamarga kshara, Reference: Susruta samhitha, Route: Topical, Dosage Form: Kshara, Dose: 20(g), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | kShArakarma, क्षारकर्म | (Procedure Reference: Susrutha samhitha, Procedure details: The gauze piece of size 23cm in diameter will be fixed to double layered circular wooden ring .
On first coating Snuhi Ksheera( 50ml) will be smeared on gauze piece and kept in the UV Ksharasutra cabinet and dried.
On second coating Snuhi Ksheera( 50ml) will be smeared over the gauze piece followed by Shweta Arka mrudu Kshara ( 20gram) application and kept in the UV Ksharasutra cabinet and dried.
On third coating Snuhi Ksheera will be smeared followed by Haridra choorna ( 20gram) application and kept in the UV Ksharasutra cabinet and dried.
Stored in sterile polythene bag.
) (1) Medicine Name: Swetha arka kshara, Reference: Susrutha samhitha, Route: Topical, Dosage Form: Kshara, Dose: 20(g), Frequency: od, Duration: 7 Days |
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Inclusion Criteria
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| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Irrespective of Gender, religion and occupation.
• Diagnosed cases of diabetic foot ulcers within 7 cm× 8 cm size (56 cm2 area)
• Diabetic foot of grade 1 &2 as per Meggitt’s classification.
• Diabetic Foot Ulcers in controlled Diabetes Mellitus patients. (HbA1c within 7%)
• Subjects with Dorsalis Pedis Artery &Posterior Tibial Artery pulsations
|
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| ExclusionCriteria |
| Details |
• Patients Suffering from systemic disorders like Tuberculosis, uncontrolled HTN and HIV.
• Pregnant and lactating women.
• Wounds near major arteries and veins.
• Gangrenous ulcers, Tubercular ulcers, osteomyelitis and Ulcers with pre gangrenous changes.
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Method of Generating Random Sequence
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Coin toss, Lottery, toss of dice, shuffling cards etc |
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Method of Concealment
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Not Applicable |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
Subjects are assessed on the basis of subjective and objective parameters.SUBJECTIVE PARAMETERS:
• Pain
• Burning sensation
• Itching
OBJECTIVE PARAMETERS:
• Size of the wound
• Colour
• Discharge
• Odour
• Granulation tissue
|
42 days |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
The intervention will be carried out until the attainment of Shuddhavrana
lakshanas.
|
1 week
|
|
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Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
N/A |
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Date of First Enrollment (India)
|
15/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/08/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
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Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
NEED FOR THE STUDY:
The word “Vrana” derived
from the root word “Vran” means the splitting/tearing of the tissue and eventually
leaves an imprint1. Dushta vrana which can be co-related to
any non healing ulcer and it is more crucial to debride, promote
epithelialization and make it possible to reach healthy granulation tissue. If this ulcer left untreated or not
properly treated, they can lead to complications.
In present era, about 60% of
diabetics will develop neuropathy, eventually leading to foot ulcer. The common
causes are poor control of blood sugar level, foot deformities and improper
care.
Annual incidence of diabetic
foot ulcer World wide is between 9.1-26.1 millions2. Around 15 – 25% of those will develop foot ulcer
during their life time3. Overall about 5% of diabetic patients
develop foot ulcer and 1% of them end up in amputation.
Diabetic foot ulcers(DFUs) (30.5%), for
example, have a comparable 5-year mortality rate to cancer (31%),which has
remain unchanged since 2007 and yet funding for studies related to these
life-threatening complications remains significantly lower than that for cancer
research4 .
Despite recent advances in antibiotics,
topical creams, skin grafting, reconstructive surgery, and other medical
treatments, it is still impossible to prevent gangrene. Managing diabetic
wounds has never been an easy task for surgeons. This issue has seen as an
ensuing need for amputation. Finding effective and secure interventions and
medications is an ongoing search given the seriousness of the disease and lack
of appropriate treatments.
Acharya
Sushsruta mentioned Kshara
Karma as one among Shasti upakrama of vrana 5.
Kshara is an alkaine substance prepared through classical methodology,
having Chedana, Bhedana, Lekhana, tridoshagna6 properties
also described as Anushastra and Upayantra.
Acharya
Sushruta mentioned various types of bandaging techniques and bandaging materials
for healing purposes in different forms like Vikeshika, Kavalika, Plota and
Pichu7. Among them Plota is selected for the study.
Studies have found that Ksharaplota is having Shodhana , Ropana properties.
Ksharaplota offers distruction of unhealthy tissues, draining of
the debris and simultaneously enhances granulation process. Combination of Shweta
Arka kshara, Snuhi ksheera and Haridra having
lekhana, shodhana and ropana properties, promotes neovascularization
and faster wound healing by its anti-inflammatory,
anti-microbial and antioxidant activities.
Here is an attempt made to
evaluate the efficacy of Shweta Arka Ksharaplota and to compare its efficacy
with Apamarga kshara plota in the management of Kaphaja Dushta vrana Vis-à-vis Diabetic
foot ulcer.
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