| CTRI Number |
CTRI/2025/04/084839 [Registered on: 15/04/2025] Trial Registered Prospectively |
| Last Modified On: |
15/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to understand the variation in blood sugar level after ayurvedic enema therapy |
|
Scientific Title of Study
|
An Observational Study To Analyze The Pattern Of Blood Glucose Fluctuations During The Administration Of Niruha Vasti |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aby Cheriyan |
| Designation |
PG Scholar |
| Affiliation |
Amrita school of Ayurveda |
| Address |
Department of Panchakarma
Amrita School of Ayurveda
Amrita Vishwa Vidyapeetham,
Clappana P.O.Kerala, India.
Kollam
KERALA
690525
India |
| Phone |
6361240145 |
| Fax |
|
| Email |
abycheriyan15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vishnu U |
| Designation |
Associate Professor |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Department of Panchakarma
Amrita School of Ayurveda
Amrita Vishwa Vidyapeetham,
Clappana P.O.Kerala, India.
Kollam
KERALA
690525
India |
| Phone |
9567198958 |
| Fax |
|
| Email |
pillaidrvishnu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr K Parameswaran Namboothiri |
| Designation |
Professor |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Department of Panchakarma
Amrita School of Ayurveda
Amrita Vishwa Vidyapeetham,
Clappana P.O.Kerala, India.
Kollam
KERALA
690525
India |
| Phone |
9496096694 |
| Fax |
|
| Email |
nambu24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita School of Ayurveda,
Amritapuri, Clappana P.O, Vallickavu, Kollam
Kerala- 690525 |
|
|
Primary Sponsor
|
| Name |
Dr Aby Cheriyan |
| Address |
Department of Panchakarma
Amrita School of Ayurveda
Amrita Vishwa Vidyapeetham, Amritapuri, Clappana P.O. Kerala, India - 690 525. |
| 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 Aby Cheriyan |
Amrita school of ayurveda |
Room number 2
Department of Panchakarma
Amrita School of Ayurveda,
Clappana P.O.Kerala, India.
Kollam
KERALA |
6361240145
abycheriyan15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Amrita Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M150||Primary generalized (osteo)arthritis. Ayurveda Condition: VATAVYADHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing nirooha basti pattern without anuvasana basti
patients with HbA1c below the range of 5.7%
|
|
| ExclusionCriteria |
| Details |
Individuals with conditions that could significantly confound blood glucose levels, |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of blood glucose level by using a glucometer |
0th day to 5th day, just before and after administration of vasti karma. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of Samyakh Vasti lakshana |
1st day to 5th day, after administration of vasti karma. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/06/2025 |
| 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 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
|
This study is an observational analysis of blood glucose fluctuations during the administration of Niruha Basti, a therapeutic enema procedure used in Ayurveda, especially to treat Vata Vyadhis like general osteoarthritic conditions. Since Niruha Basti is administered on an empty stomach, it may influence blood glucose levels, potentially increasing the risk of hypoglycemia.The study aims to monitor and evaluate these fluctuations using randomized blood sugar measurements before and after the procedure. If blood glucose fluctuations are observed, further research can investigate the underlying cause and potential preventive measures. Statistical analysis will be conducted using repeated measures ANOVA or its non-parametric equivalents |