| CTRI Number |
CTRI/2026/02/104155 [Registered on: 18/02/2026] Trial Registered Prospectively |
| Last Modified On: |
17/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda Other (Specify) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Panchatiktaka Niruha Basti in gut microbiome of Type 2 Diabetes Mellitus |
|
Scientific Title of Study
|
Exploratory Clinical trial on the Effect of Panchatiktaka Niruha Basti in modulating Gut microbiome in Type II 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 |
Thiruharini S K |
| Designation |
PG Scholar Department of Panchakarma |
| Affiliation |
Government Ayurveda college Thiruvananthapuram |
| Address |
PG scholar
Department of Panchakarma
Government Ayurveda College
Thiruvananthapuram PG scholar
Department of Panchakarma
Government Ayurveda College
Thiruvananthapuram Thiruvananthapuram KERALA 695001 India |
| Phone |
8220822188 |
| Fax |
|
| Email |
drhariniayurveda@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ambili Krishna |
| Designation |
Associate Professor of Dept of Panchakarma |
| Affiliation |
Government Ayurveda college Thiruvananthapuram |
| Address |
Department of Panchakarma
Government Ayurveda College
Thiruvananthapuram Department of Panchakarma
Government Ayurveda College
Thiruvananthapuram Thiruvananthapuram KERALA 695001 India |
| Phone |
9847827220 |
| Fax |
|
| Email |
dr.ambilikrishna@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Ambili Krishna |
| Designation |
Associate Professor of Dept of Panchakarma |
| Affiliation |
Government Ayurveda college Thiruvananthapuram |
| Address |
Department of Panchakarma
Government Ayurveda College
Thiruvananthapuram Department of Panchakarma
Government Ayurveda College
Thiruvananthapuram Thiruvananthapuram KERALA 695001 India |
| Phone |
08220822188 |
| Fax |
|
| Email |
drhariniayurveda@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda Medical College and Hospital
Thiruvanthapuram - 695001
Kerala
India
Thiruvananthapuram |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [] |
|
|
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 |
| Thiruharini S K |
Government Ayurveda Panchakarma Hospital |
Government Ayurveda Panchakarma Hospital
Poojappura Thiruvananthapuram KERALA |
08220822188
drhariniayurveda@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee Government Ayurveda College Thiruvananthapuram |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: PRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Charaka samhita Siddhi sthana, Procedure details: Local abyanga and bhaspa sweda before vasti administration. 612ml of panchatiktaka niruha vasti administered for 7 days duration) (1) Medicine Name: Panchatiktaka Niruha vasti, Reference: charaka samhita siddhi sthana, Route: Rectal, Dosage Form: Not Applicable, Dose: 612(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Participants diagnosed with DM according to WHO criteria.
Participant diagnosed for Madhumeha based on general diagnostic criteria according
to document of protocol and prevention and control of diabetes through Ayurveda MoA
Age group 40-70 years
Participant fit for Basti karma as per ayurvedic classics
No recent antibiotic use for past 1 month. |
|
| ExclusionCriteria |
| Details |
Participant with IBS, chronic diarrhoea, ulcerative colitis.
Type 1 and type 2 diabetes taking insulin
Participants having serious complication of diabetic neuropathy, nephropathy,
retinopathy, diabetic foot.
Participants with diabetes mellitus for more than 10 years.
Diabetes with CA
Pregnancy
Breast feeding |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Modulations in gut microbiome will be assessed before first day (0th day) of basti and
next day (8th day) after last basti.
|
At baseline, 1 week , 3 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in FBS & PPBS level will be recorded on 0th day & 8th day of basti to
assess glycaemic changes post - intervention |
At baseline, 1 week , 3 week |
|
|
Target Sample Size
|
Total Sample Size="8" Sample Size from India="8"
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)
|
16/03/2026 |
| 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)
|
Closed to Recruitment of Participants |
| 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
|
Type II Diabetes mellitus is a metabolic disorder of increasing global prevalence, significantly impacting quality of life through complications like neuropathy, nephropathy and cardiovascular disease. Ayurveda identifies T2DM under the umbrella of Madhumeha, where Kapha and Meda vitiation play a central pathogenic role. Panchatiktaka Niruha Basti, a medicated enema therapy described in Ayurvedic texts, is traditionally indicated in the management of Prameha, including Madhumeha, and is proposed to exert systemic effects via the gut. The aim of this study is to evaluate the efficacy of Panchatiktaka Niruha Basti in modulating gut microbiome composition and improving glycemic parameters in patients with T2DM. A single-arm Exploratory clinical trial will be conducted on T2DM patients aged 40–70 years meeting specific inclusion and exclusion criteria. The intervention involves administration of Panchatiktaka Niruha Basti (612 ml) for 7 consecutive days following standard Ayurvedic preparatory procedures. Stool samples will be collected pre- and postintervention for gut microbiome analysis using 16S rRNA sequencing. Alpha and beta diversity will be performed to understand changes in richness and evenness (within sample diversity) and microbial community composition (between sample diversity) pre and post intervention. Clinical assessments and glycemic markers (FBS, PPBS, HbA1c) will be recorded. Data will be analyzed using appropriate statistical tools, including PERMANOVA, to detect shifts in bacterial diversity and relative abundance. |