| CTRI Number |
CTRI/2024/08/073022 [Registered on: 28/08/2024] Trial Registered Prospectively |
| Last Modified On: |
27/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Hypoglycemic effect of Mooviladi kashaya in Type 2 Diabetes mellitus |
|
Scientific Title of Study
|
Effect of Mooviladi kashaya
in Type 2 Diabetes mellitus. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
STEFY JOSEPH |
| Designation |
PG Scholar |
| Affiliation |
Poomulli Neelakandan Namboodiripad Memorial Ayurveda Medical College and Hospital |
| Address |
Department of kayachikitsa Poomulli Neelakandan Namboodiripad Memorial Ayurveda Medical College and Hospital Cheruthuruthy PO
Thrissur
Poomulli Neelakandan Namboodiripad Memorial Ayurveda Medical College and Hospital Cheruthuruthy PO
Thrissur 679531
Thrissur
KERALA
679531
India |
| Phone |
9809782131 |
| Fax |
|
| Email |
stelizjos@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Surej Subash |
| Designation |
Professor Department of Kayachikitsa |
| Affiliation |
Poomulli Neelakandan Namboodiripad Memorial Ayurveda Medical College and Hospital |
| Address |
Department of Kayachikitsa
Poomulli Neelakandan Namboodiripad Memorial Ayurveda Medical College and Hospital Cheruthuruthy PO
Thrissur
Poomulli Neelakandan Namboodiripad Memorial Ayurveda Medical College and Hospital Cheruthuruthy PO
Thrissur 679531
679531
Thrissur
KERALA
679531
India |
| Phone |
8943438383 |
| Fax |
|
| Email |
drsurej@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinitha C |
| Designation |
Associate professor Department of Kayachikitsa |
| Affiliation |
Poomulli Neelakandan Namboodiripad Memorial Ayurveda Medical College and Hospital |
| Address |
Department of Kayachikitsa
Poomulli Neelakandan Namboodiripad Memorial Ayurveda Medical College and Hospital Cheruthuruthy PO
Thrissur
Poomulli Neelakandan Namboodiripad Memorial Ayurveda Medical College and Hospital Cheruthuruthy PO
Thrissur 679531
Thrissur
KERALA
679531
India |
| Phone |
9497062425 |
| Fax |
|
| Email |
drvinithasujith@gmail.com |
|
|
Source of Monetary or Material Support
|
| PNNM Ayurveda Medical College and Hospital Cheruthuruthy PO Thrissur Kerala India |
|
|
Primary Sponsor
|
| Name |
STEFY JOSEPH |
| Address |
2nd year PG scholar Department of Kayachikitsa PNNM Ayurveda Medical College Cheruthuruthy PO Thrissur |
| 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 STEFY JOSEPH |
PNNM Ayurveda Medical College and Hospital |
Department of Kayachikitsa Poomulli Neelakandan Namboodiripad Memorial Ayurveda Medical College and Hospital
Cheruthuruthy PO
679531
Thrissur
Kerala
Thrissur
KERALA |
9809782131
stelizjos@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee PNNM Ayurveda Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E11||Type 2 diabetes mellitus. Ayurveda Condition: PRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Mooviladi kashaya, Reference: NA, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 15(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Water and honey), Additional Information: Water 45 ml
Honey 6 gm |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants fulfilling the diagnostic criteria
Participants diagnosed with Type 2 Diabetes mellitus within 2 years
Participants willing to sign the informed consent form
Participants having any or both the blood glucose levels with following ranges
FBS - 126mg/dl to 250mg/dl
RBS- 200mg/dl to 350mg/dl |
|
| ExclusionCriteria |
| Details |
Participants diagnosed with Type 1 Diabetes mellitus
Participants who are known case of other systemic illness
Participants who are known cases of psychiatric illness
Pregnant and lactating women
HbA1c greater than 8.5 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
FBS
RBS
Polyuria
Polyphagia
Polydipsia
Excessive Sweating
Fatigue |
Assessment on 0th and 31st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of Life |
Assessment on 0th & 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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
07/09/2024 |
| 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
|
This study is a single arm trial for assessing the effect of Mooviladi kashaya in 30 patients with Type 2 diabetes mellitus for a period of 30 days with a dose of 15 ml by adding 45 ml boiled and cooled water and 6 gm of honey twice a day before food. The study will be conducted at PNNM ayurveda medical college Thrissur district, Kerala. The primary outcome measures are the signs and symptoms which will be assessed on 0th and 31st day. Secondary outcome measures are FBS, RBS and Quality of life which will be assessed on 0th and 31st day. |