| CTRI Number |
CTRI/2025/01/079623 [Registered on: 28/01/2025] Trial Registered Prospectively |
| Last Modified On: |
25/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Amruthadi yogam in diabetic neuropathic burning sensation |
|
Scientific Title of Study
|
Effect of Amruthadi yoga as an add on to conventional therapy in small fibre diabetic neuropathy |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jisha S |
| Designation |
First year pg scholar |
| Affiliation |
Government ayurveda college Thiruvananthapuram |
| Address |
Department of Rasasastra and Bhaishajya kalpana
Government ayurveda college Thiruvananthapuram
Thiruvananthapuram
KERALA
695001
India |
| Phone |
9061447366 |
| Fax |
|
| Email |
jishashaji14996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sreeni T V |
| Designation |
Professor and HOD |
| Affiliation |
Government ayurveda college Thrippunithara |
| Address |
Department of Rasasastra and Bhaishajya kalpana
Government ayurveda college Thrippunithara
Thiruvananthapuram
KERALA
682301
India |
| Phone |
9447500829 |
| Fax |
|
| Email |
drsreenitv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jisha S |
| Designation |
First year pg scholar |
| Affiliation |
Government ayurveda college Thiruvananthapuram |
| Address |
Department of Rasasastra and Bhaishajya kalpana
Government ayurveda college Thiruvananthapuram
Thiruvananthapuram
KERALA
695001
India |
| Phone |
9061447366 |
| Fax |
|
| Email |
jishashaji14996@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda college thiruvananthapuram kerala 695001 |
|
|
Primary Sponsor
|
| Name |
Government Ayurveda college thiruvananthapuram kerala 695001 |
| Address |
Department of rasasasthra and bhaishajya kalpana Government Ayurveda college thiruvananthapuram kerala 695001 |
| Type of Sponsor |
Research institution |
|
|
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 Jisha S |
Government Ayurveda college Thiruvananthapuram |
Department of Rasasasthra and Bhaishajya kalpana opd-1,Government Ayurveda College Thiruvananthapuram
Thiruvananthapuram
KERALA |
9061447366
jishashaji14996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee Government Ayurveda College Thiruvananthapuram |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G64||Other disorders of peripheral nervous system. Ayurveda Condition: PRAMEHA-UPADRAVAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Amruthadi yogam, Reference: Yogamrutham prameha chikitsa adhyaya sloka number 18 , Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Muhurmuhu, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed cases of Small fibre diabetic neuropathy presenting with burning sensation |
|
| ExclusionCriteria |
| Details |
Participants exhibiting burning sensation as a result of hormonal,drug induced or other factors,Diabetic foot ulcers |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in burning pain using neuropathic pain scale |
assessment done on 1st day 14th day and 31st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in quality of life using NeuroQoL |
assessment done on 1st day 14th day and 31st 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)
|
15/02/2025 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The above study deals with effect of amruthadi yoga as an add on to conventional therapy in small fibre diabetic neuropathy.Evaluation is made on change in burning pain using neuropathic pain scale and improvement in quality of life using NeuroQoL. |