| CTRI Number |
CTRI/2025/04/085297 [Registered on: 21/04/2025] Trial Registered Prospectively |
| Last Modified On: |
28/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To evaluate the action of Apamarga Hydrogel in the Management of Diabetic Ulcers. |
|
Scientific Title of Study
|
A Randomized Open Label Controlled Clinical Study To Evaluate The Efficacy of Apamarga Hydrogel in the Management of Dushta Vrana With Special Reference To Grade 1 and 2 Diabetic Ulcers |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sai Dakshini |
| Designation |
PG Scholar |
| Affiliation |
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH |
| Address |
Department of PG studies in Shalya Tantra,
Sri Sri College of Ayurvedic Science and research
21st km,Kanakapura road
Udayapura Post, Bengaluru-560082
Bangalore
KARNATAKA
560082
India |
| Phone |
9840644510 |
| Fax |
|
| Email |
dakshiniraja@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. KM Sweta |
| Designation |
PROFESSOR AND HOD |
| Affiliation |
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH |
| Address |
Department of PG studies in Shalya Tantra,
Sri Sri college of Ayurvedic Science and Research,
21st km,Kanakapura road,
Udayapura post, Bengaluru-560082
Bangalore
KARNATAKA
560082
India |
| Phone |
9902521973 |
| Fax |
|
| Email |
dr.swetatyagi1882@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sai Dakshini |
| Designation |
PG Scholar |
| Affiliation |
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH |
| Address |
Department of PG studies in Shalya Tantra,
Sri Sri college of Ayurvedic Science and Research,
21st km,Kanakapura road,
Udayapura post, Bengaluru-560082
Bangalore
KARNATAKA
560082
India |
| Phone |
9840644510 |
| Fax |
|
| Email |
dakshiniraja@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Sri college of Ayurvedic Science and Research,
21st km,Kanakapura road,
Udayapura post, Bengaluru-560082 |
|
|
Primary Sponsor
|
| Name |
Dr Sai Dakshini |
| Address |
Sri Sri college of Ayurvedic Science and Research
21st km Kanakapura road
Udayapura post Bengaluru 560082 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sai Dakshini |
Sri Sri College of Ayurvedic Research and Science Hospital |
Department of PG studies in Shalya Tantra,
Sri Sri college of Ayurvedic Science and Research,
21st km,Kanakapura road,
Udayapura post, Bengaluru-560082
Bangalore
KARNATAKA |
9840644510
dakshiniraja@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Sri Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E116||Type 2 diabetes mellitus with other specified complications. Ayurveda Condition: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | HYDROHEAL AM | HYDROHEAL AM COLLOIDAL DRESSING WITH SILVER - FOR TOPICAL APPLICATION | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: APAMARGA HYDROGEL, Reference: NA, Route: Topical, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 1(mg), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects with Diabetic Ulcers Of Grade 1 And 2 (As Per University Of Texas Classification Of Diabetic Ulcers)
2.Subjects aged between 25-70 Years irrespective Of Gender,Religion,Occupation,Economic Status And Educational Status
|
|
| ExclusionCriteria |
| Details |
1.Subjects with Ulcer Grade 3 (As Per Texas Classification Of Diabetic Ulcers)
2.Subjects suffering from Infectious Diseases Like HIV,Hepatitis, Tuberculosis or other Sexually Transmitted Infections
3.Subjects suffering from Osteomyelitis
4.Subjects suffering from Immunocompromised Diseases
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Signs of Wound Healing based on favourable changes in Bates and Jenson Wound Assessment Tool and Vas Scale |
0TH,7TH 14TH 21ST Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improved Quality of Life |
7TH 14TH 21ST Day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
27/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study has been taken up to evaluate the Efficacy of Apamarga Hydrogel in the management of Dushta Vrana with Special reference to Grade 1 and 2 Diabetic ulcers (as per University of Texas classification of Ulcers)
Comparision chosen is Hydroheal AM
Hypothesis
Null - There is no difference in the efficacy of Apamarga Hydrogel and Hydroheal AM in the management of Dushta Vrana with special reference to Grade 1 and 2 Diabetic Ulcers (as per University of Texas classification of Ulcers) H1 - Efficacy of Hydroheal AM is better than Apamarga Hydrogel in the management of Dushta Vrana with special reference to Grade 1 and 2 Diabetic Ulcers.
H2 - Efficacy of Apamarga Hydrogel is better than Hydroheal AM in the management of Dushta Vrana with special reference to Grade 1 and 2 Diabetic Ulcers. |