| CTRI Number |
CTRI/2025/03/082902 [Registered on: 20/03/2025] Trial Registered Prospectively |
| Last Modified On: |
12/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative study on the efficacy of Ayurvedic formulations in the management
of Diabetic peripheral neuropathy |
|
Scientific Title of Study
|
A COMPARATIVE STUDY ON THE EFFICACY OF SUNDIBALADWAYA
KASHAYA WITH NISHA AMALAKI CHOORNA AND SUNDIBALADWAYA
KASHAYA WITH KSHEERABALA TAILA 7 AVARTHI IN THE MANAGEMENT
OF DIABETIC PERIPHERAL NEUROPATHY: A RANDOMIZED CONTROL TRIAL |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rejeesh Skaria |
| Designation |
PG Scholar |
| Affiliation |
Vaidyaratnam Ayurveda College Thaikkattussery Ollur |
| Address |
Department of Kayachikitsa
Vaidyaratnam Ayurveda College
Thaikkattussery
Ollur
Thrissur
KERALA
680306
India |
| Phone |
7558097074 |
| Fax |
|
| Email |
drrejeeshskr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr T C Marikutty MD Ay |
| Designation |
Professor and Head of the department |
| Affiliation |
Vaidyaratnam Ayurveda College Thaikkattussery Ollur |
| Address |
Department of Kayachikitsa
Vaidyaratnam Ayurveda College
Thaikkattussery
Ollur
Thrissur
KERALA
680306
India |
| Phone |
9447829212 |
| Fax |
|
| Email |
drmarikuttytc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr T C Marikutty MD Ay |
| Designation |
Professor and Head of the department |
| Affiliation |
Vaidyaratnam Ayurveda College Thaikkattussery Ollur |
| Address |
Department of Kayachikitsa
Vaidyaratnam Ayurveda College
Thaikkattussery
Ollur
Thrissur
KERALA
680306
India |
| Phone |
9447829212 |
| Fax |
|
| Email |
drmarikuttytc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vaidyaratnam Ayurveda College
Thaikkattussery Ollur 680306
Thrissur |
|
|
Primary Sponsor
|
| Name |
Vaidyaratnam Ayurveda College Ollur |
| Address |
Vaidyaratnam Ayurveda College
Thaikkattussery Ollur 680306
Thrissur |
| Type of Sponsor |
Other [Aided College] |
|
|
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 Rejeesh Skaria |
Vaidyaratnam Ayurveda College Hospital |
OPD Department of Kayachikitsa Vaidyaratnam Ayurveda College Ollur
Thrissur
KERALA |
7558097074
drrejeeshskr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional committee for ethics in research Vaidyaratnam Ayurveda College Ollur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E114||Type 2 diabetes mellitus with neurological complications. Ayurveda Condition: PRAMEHA-UPADRAVAH, (2) ICD-10 Condition:E114||Type 2 diabetes mellitus with neurological complications. Ayurveda Condition: PRAMEHA-UPADRAVAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Sundibaladwaya kashaya , Reference: Sahasrayogam, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -Nisha amalaki choorna), Additional Information: -(2) Medicine Name: Nisha amalaki choorna, Reference: Ashtangahridaya, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Sundibaladwaya kashaya , Reference: Sahasrayogam, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -Ksheerabala taila 7 avarthI), Additional Information: -(2) Medicine Name: Ksheerabala taila 7 avarthi, Reference: Sahasrayogam, Route: Oral, Dosage Form: Taila, Dose: 1(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Diabetic peripheral Neuropathy diagnosed by diabetic peripheral neuropathy analyzer: Vibrotherm
2. Toronto Clinical Neuropathy Score (TCNS) TCNS Score equal or more than 6
3. HbA1c: between 6.5 to 8.5 |
|
| ExclusionCriteria |
| Details |
1.Diagnosed cases of cervical, thoracic and lumbar radicular neuropathy
2.Participants with type 2 DM who are under insulin medication
3.Participants with foot ulcer, amputation
4.Participants who have undergone any clinical trial during past six months
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Diabetic peripheral Neuropathy analyser:Vibrotherm
|
0TH 30TH 60TH AND 91TH DAY
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Toronto Clinical Neuropathy Score (TCNS)
2. HbA1c
|
0TH AND 91TH DAY |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
30/03/2025 |
| 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="6"
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
|
Diabetic Peripheral Neuropathy is the most common complication of Diabetes mellitus. The symptomatology corresponding to the clinical presentation of Diabetic peripheral neuropathy is scattered in Purvarupa (premonitory symptoms) Lakshana (symptoms) and Upadrava (complications) of Prameha. It can be compared under the broad head of Prameha janya upadrava as it manifests secondary to Diabetes mellitus. It can be treated in dual line of treatment directed at the main disease Prameha and its complications. It will have the same Nidaana, Dosha, and Dushyas as that of the main Disease, though they have Samprapti of its own. When main Disease is managed well complications will disappear. This study focuses on the combined effect of premeha chikitsa and its upadrava chikitsa together in the management of diabetic peripheral neuropathy. Treating the main disease is very much important in the management of a complication. So, a comparative study of Sundibaladwaya kashaya with Nisha amalaki Choornam and Sundibaladwaya kashaya with Ksheerabala taila 7 avarthi is planned. The participants are selected randomly and given this combination of medicines in an alternate basis and the effect is analysed by neuropathy analyser Vibrotherm and Toronto Clinical Neuropathy Score (TCNS) |