| CTRI Number |
CTRI/2025/12/099231 [Registered on: 16/12/2025] Trial Registered Prospectively |
| Last Modified On: |
16/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
This study checks how a special Ayurvedic enema therapy helps people with diarrhoea-type IBS and how it affects the good bacteria in the gut. |
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Scientific Title of Study
|
Effectiveness of Dwadashaprasutha Grahi Vasti in Yogavasti Schedule in Diarrhoea Predominant Irritable Bowel Syndrome and Gut Microbiota analysis in Sub Sample |
| Trial Acronym |
NIL |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrJasmin A V |
| Designation |
PG Scholar Department of Panchakarma |
| Affiliation |
Government Ayurveda College and Hospital Tripunithura |
| Address |
OP Number 5,
Department of Panchakarma
Government Ayurveda College and Hospital Tripunithura Puthiyakavu
Ernakulam
KERALA
682301
India |
| Phone |
8330022963 |
| Fax |
|
| Email |
jasminasha06@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Seena S |
| Designation |
Professor and HOD Department of Panchakarma |
| Affiliation |
Government Ayurveda College and Hospital Tripunithura |
| Address |
OP Number 5
Department of Panchakarma
Government Ayurveda Medical College and Hospital Tripunithura Puthiyakavu
Ernakulam
KERALA
682301
India |
| Phone |
9447190133 |
| Fax |
|
| Email |
seenas279@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Seena S |
| Designation |
Professor and HOD Department of Panchakarma |
| Affiliation |
Government Ayurveda College and Hospital Tripunithura |
| Address |
OP Number 5
Department of Panchakarma
Government Ayurveda Medical College and Hospital Tripunithura Puthiyakavu
Ernakulam
KERALA
682301
India |
| Phone |
9447190133 |
| Fax |
|
| Email |
seenas279@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda College Hospital Tripunithura
Puthiyakavu Ernakulam Dist
Pin:682301 |
|
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Primary Sponsor
|
| Name |
Government Ayurveda College Tripunithura |
| Address |
Government Ayurveda College Hospital Tripunithura
Puthiyakavu Ernakulam Kerala India
Pin 682301 |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Jasmin A V |
Government Ayurveda College Tripunithura Puthiyakavu |
OPD 5 and IPD Department of Panchakarma
Government Ayurveda College Tripunithura Puthiyakavu
Ernakulam
Pin 682301
Ernakulam
KERALA |
8330022963
jasminasha06@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL COMMITTEE FOR ETHICS IN RESEARCH |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K928||Other specified diseases of the digestive system. Ayurveda Condition: GRAHANIDOSHAH, |
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Intervention / Comparator Agent
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| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | vaitaraNa-bastiH, वैतरण-बस्तिः | (Procedure Reference: Susrutha samhita chikitsa sthana 38th chapter Niruhakrama chikitsitham, Procedure details: Grahi vasti is a type of vasti mentioned by acharya susrutha.In this present study dwadashaprasrutha grahi vasi(24 pala) is administered in yogavasti schedule for 8 days in diagnosed cases of diarrhoea predominant IBS patients.The schedule consists of both anuvasanavasti and niruhavasti.Anuvasana vasti will be done in between 1-2 pm just aftr intake of food.In anuvasana vasti 288 ml of changeryadi ghritam is administered.During anuvasana vasti,after having food and evacuating the urges,patient is asked to lie on left lateral position .After doing local abhyanga and ushmasweda ,wearing the hand gloves per rectal examiamation is done .Later medicine is administered through anus.After the administration of medicine patient is asked to lie in supine position and bend the legs in knee.Then advise to take rest.During the administration of niruhavasti ,vasti medicine is prepared by triturating the medicines in the order of saindhava(12gm),madhu(192 ml),changeryadi ghritm(288 ml),ambashtadi gana kalkam(144gm),priyanguadi gana kashayam(384 ml) and takram(144 ml).After doing local sneha sweda vasti medicine is administered in left lateral position.Advise the patient to lie in supine position until the urge for defecation occurs.After the elimination of medicine and stool advisethe patient to take lukewarm water bath and take food.
For the analysis of gut microbiota,stool sample is collected from 7 subjects(as subsample)on 0th day and 25th day of vasti adminisration.)
(1) Medicine Name: Changeryadi ghritm, Reference: Susrutha samhita chikitsa sthana 38th chapter Niruhakrama chikitsitham, Route: Rectal, Dosage Form: Ghrita, Dose: 288(ml), Frequency: od, Duration: 8 Days(2) Medicine Name: Ambashtadi gana kalka, Reference: Susrutha samhita chikitsa sthana 38th chapter Niruhakrama chikitsitham, Route: Rectal, Dosage Form: Kalka/ Paste, Dose: 144(g), Frequency: od, Duration: 3 Days(3) Medicine Name: Priyanguadi gana kashayam, Reference: Susrutha samhita chikitsa sthana 38th chapter Niruhakrama chikitsitham, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 384(ml), Frequency: od, Duration: 3 Days(4) Medicine Name: Saindhavam, Reference: Susrutha samhita chikitsa sthana 38th chapter Niruhakrama chikitsitham, Route: Rectal, Dosage Form: Lavana, Dose: 12(g), Frequency: od, Duration: 3 Days(5) Medicine Name: Madhu, Reference: Susrutha samhita chikitsa sthana 38th chapter Niruhakrama chikitsitham, Route: Rectal, Dosage Form: Not Applicable, Dose: 192(ml), Frequency: od, Duration: 3 Days(6) Medicine Name: Takram, Reference: Susrutha samhita chikitsa sthana 38th chapter Niruhakrama chikitsitham, Route: Rectal, Dosage Form: Not Applicable, Dose: 144(ml), Frequency: od, Duration: 3 Days |
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Participants with IBS as per ROME4 criteria
Participants fit for Niruhavasti and Anuvasana vasti
Age group 20 to 50 years
Willing to give consent
|
|
| ExclusionCriteria |
| Details |
Diagnosed with Inflammatory bowel disease,colonic neoplasm,acute gastro intestinal condition
Diagnosed case of systemic diseases like TB,HIV,Cardiac diseases and renal diseases
Diagnosed case of uncontrolled Type2 diabetic mellitus,systemic hypertension,pregnant women and lactating mother
Severe cases of IBS (IBS-Symptom severity scale score greater than 300) |
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
1.The subject will be assessed using the IBS Symptom severity scale on 0th day,9th day,25th day
2.The stool examination using Real time PCR will be done on 0th day and 25th day |
0th day,9th day,25th day
|
|
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Secondary Outcome
|
| Outcome |
TimePoints |
1.To evaluate reduction in symptoms of grahani
2.Assessment of samyak niruha lakshana of dwadashaprasrutha grahi vasti as per samhitas on 3rd,5th and 7th day |
3rd day,5th day,7th day |
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Target Sample Size
|
Total Sample Size="27"
Sample Size from India="27"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 3 |
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Date of First Enrollment (India)
|
27/12/2025 |
| 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" |
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Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
Irritable Bowel Syndrome is a prevalent functional bowel disorder .This study is to evaluate the effectiveness of dwadashaprasrutha grahi vasti in diarrhoea predominant Irritable bowel syndrome in yogavasti schedule in diagnosed cases of IBS where in anuvasana vasti is done with changeryadi ghrita and niruha vasti with dwadashaprasrutha grahi vasti. Assessment is done using IBS -Symptom severity scale on 0th,9th and 25th day .Clinical trial will be conducted using this protocol for 27 subjects among the age group 20-50 years satisfying the inclusion and exclusion crteria attending the IPD of Government Ayurveda College Tripunithura.Also gut microbiota analysis will be conducted before and after the administration of yogavasti in a sub sample of 7 subjects through Real time PCR on 0th and 25th day. |