| CTRI Number |
CTRI/2025/12/098330 [Registered on: 02/12/2025] Trial Registered Prospectively |
| Last Modified On: |
16/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Ayurvedic Decoction Enema in the management of Irritable Bowel Syndrome. |
|
Scientific Title of Study
|
Clinical Study to Evaluate the Effect of Shampakadi Niruha Basti in Grahani w.s.r. to Irritable Bowel Syndrome(IBS). |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yasir Sameer Dabir |
| Designation |
PG Scholar |
| Affiliation |
College of Ayurved, Bharati Vidyapeeth, Pune |
| Address |
Department of Panchakarma, College of Ayurved, Bharati Vidyapeeth (Deemed to be University), Dhankawadi, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
7498590067 |
| Fax |
|
| Email |
yasir.dabir-ayurved@bvp.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Santosh E Chavan |
| Designation |
Professor and Head of Department, Panchakarma |
| Affiliation |
College Of Ayurved, Bharati Vidyapeeth, Pune |
| Address |
Department of Panchakarma, College of Ayurved, Bharati Vidyapeeth (Deemed to be University), Dhankawadi, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9822249807 |
| Fax |
|
| Email |
santosh.chavan@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Santosh E Chavan |
| Designation |
Professor and Head of Department, Panchakarma |
| Affiliation |
College Of Ayurved, Bharati Vidyapeeth, Pune |
| Address |
Department of Panchakarma, College of Ayurved, Bharati Vidyapeeth (Deemed to be University), Dhankawadi, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9822249807 |
| Fax |
|
| Email |
santosh.chavan@bharatividyapeeth.edu |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth(Deemed to be University), Dhanakawadi, 411043, Pune, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Dr Yasir Sameer Dabir |
| Address |
Department of Panchakarma, College of Ayurved and Hospital, Bharati Vidyapeeth (Deemed to be University), Dhanakawadi, 411043, Pune, Maharashtra, India |
| 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 Yasir Sameer Dabir |
College of Ayurved and Hospital, Bharati Vidyapeeth Deemed to be University |
Bharati vidyapeeth
(Deemed to be)
University, Bharati
Ayurved Hospital,
Department Of
Panchakarma OPD No
21, Dhankawadi, Katraj,
Pune
Pune
MAHARASHTRA |
7498590067
yasir.dabir-ayurved@bvp.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BHARATI VIDYAPEETH (DEEMED TO BE UNIVERSITY), PUNE (INDIA) COLLEGE OF AYURVED PUNE-SATARA ROAD, PUNE 411 043. INSTITUTIONAL ETHICS COMMITTEE BV(DU)COA IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K582||Mixed irritable bowel syndrome. Ayurveda Condition: GRAHANIDOSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Sushruta Samhita Chikitsasthan, Procedure details: Murchita Tila Tail Anuvasan Basti & Shampakadi Niruha Basti, by Yoga Basti Krama.)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having classical signs and symptoms of Muhur-Baddha Muhur-Drava mala pravrutti,
Picchila Malapravrutti, Aruchi, Adhman, Tikta Amlodgar, Antrakujan and Balakshay.
Awastha of Grahani in which there is Agnimandya and Purish, Mutra and Maruta Avarodh.
Diagnosis with active Irritable Bowel Syndrome symptoms as indicated by a score between (75 - 299
on IBS SEVERITY SCORING SYSTEM)
Patient Arha for Basti Karma. |
|
| ExclusionCriteria |
| Details |
More than 3 years chronicity of Grahani.
Known cases of systemic diseases like Hypertension
Cases of Anorectal diseases and Colon Resection Surgeries
Patients Anarha for Basti karma
Pregnant women and lactating mothers. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcomes will include improvement in the clinical features of Grahani.
Symptom Score Reduction :
Muhurbaddha Muhurdrava Mala (Episode of hard & loose stools)
Adhman (Distention of Abdomen)
Balakshaya (Weakness)
Picchila Malapravrutti (Passing mucus in stool)
Aruchi (Anorexia) Tikta-Amlodgara (Iron pungent odour burps)
Antrakujana (Gurgling sound in abdomen) |
Base Line, 9th Day, 30th Day, 45th Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary assessments may include standardized tools such as the Gastrointestinal Symptoms
Rating Scale (GSRS), IBS Severity Scoring System (IBS-SSS) and Bristol Stool Chart to
correlate with modern GI symptomatology. |
Base Line, 9th Day, 30th Day, 45th Day |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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 |
|
Date of First Enrollment (India)
|
15/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/12/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Grahani is having NAMC Code ICD-601 EB-7(1) (disorders of lower Gastro Interstinal tract). Grahani is a chronic gastrointestinal disorder described in Ayurveda under the spectrum of Ashta Mahagada (major diseases) by Acharya Vagbhat. It is primarily a dysfunction of Agni (digestive fire), especially Jatharagni, leading to improper digestion and assimilation of food. The seat of Grahani is considered to be the Grahani organ itself, located anatomically near the Amashaya and Pakvashaya, and physiologically responsible for the retention and release of digested food. According to Acharya Charak, Grahani is a disease which is originated from Mandagni (weak digestion), resulting in the formation of Ama (toxic undigested metabolites), which causes symptoms such as Muhur-Baddha Muhur-Drava, Picchila Mala pravrutti, Aruchi, Asyavairasya, Adhman, Antrakujan, Balakshay and Loha-Amagandhi-Tikta-Amla Udgar(2). It can be correlated with conditions such as irritable bowel syndrome (IBS) in modern medicine. The clinical features of Grahani closely resembles to Irritable Bowel Syndrome (IBS) ICD Code- K 58(1), a functional gastrointestinal disorder marked by abdominal pain or discomfort along with altered bowel habits, despite the absence of any detectable structural abnormalities. Since there are no definitive diagnostic tests for IBS, its diagnosis primarily depends on clinical symptoms by GSRS and IBS Score. IBS is among the most frequently observed conditions in medical practice, yet it remains poorly understood. Globally, approximately 10–20% of adolescents and adults exhibit symptoms consistent with IBS, with a higher incidence reported in females. The severity of symptoms may vary widely, often leading to a considerable decline in quality of life and increased healthcare expenses. Current treatment approaches in modern medicine mostly offer symptomatic relief and may sometimes lead to adverse effects. This creates a promising opportunity for Ayurveda as main line of treatment, to explore more effective and holistic treatment options for IBS. Acharya Sushruta mentioned Shampakadi Basti, a type of Asthapan Basti (decoction-based enema), is mentioned in Ayurvedic texts for its Deepana-Pachana, Vata-Kapha shamaka, and Grahani-hara actions. Niruha Basti is considered one of the most effective therapeutic procedures in Panchakarma for Pakvashaya gata Vata and Grahani disorders. The Study will be consisting of one Group as per the inclusion criteria that group will receive Yoga Basti Krama using Shampakadi Niruha Basti and Murchita Tila Taila Anuvasana Basti for 8 days. |