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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-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.
 
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