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Clinical Trials/CTRI/2024/12/078473
CTRI/2024/12/078473Not yet recruitingNot Applicable

A Comparative Clinical Trial on Efficacy of Takravasti and Sangrahi vasti done as Kalavasti in modulating Gut microbiome in Irritable Bowel Syndrome (IBS)

Vaidyaratnam PS Varier Ayurveda College1 site in 1 country8 target enrollmentStarted: December 23, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
8
Locations
1
Primary Endpoint
Modulation in gut microbiome

Study Overview

Brief Summary

Irritable bowel syndrome (IBS) is a functional gastrointestinal disorder characterized by a group of symptoms that commonly include abdominal pain, abdominal bloating, associated with altered bowel habits. The exact cause of IBS is unknown, research suggests that the gut microbiome plays a significant role. A healthy gut microbiome is diverse and balanced. In people with IBS, the gut microbiome is found to be less diverse. This imbalance, called gut dysbiosis, contributes to IBS symptoms. Though it is not possible to find an exact correlation of IBS in AÌ„yurveda, some of the disorders such as VaÌ„taja and Kaphaja AtisaÌ„ra, Sangraha GrahanÌ£iÌ„, PravaÌ„hikaÌ„, Pakvashayagata vaÌ„ta have similarity with IBS. The treatment principle in AÌ„yurveda consists of DiÌ„pana, PaÌ„cana measures initially, followed by GraÌ„hiÌ„ and Stambhana measures by means of Vasti karma, ŚamanaosÌ£adhi, PathyaÌ„pathya etc. There is a reference of SaṅgraÌ„hi Vasti in SuśrutasamÌ£hitaÌ„ and AÌ„caÌ„rya Dalhana in his commentary suggests to add Takra as AÌ„vaÌ„pa dravya in SaṅgraÌ„hi Vasti. It has been reported a study that both SaṅgraÌ„hi vasti and Takravasti done as KaÌ„lavasti were found to be equally effective in the management of IBS. But whether it can correct the underlying pathophysiology, especially the gut microbiome is not studied yet. Hence a study is planned to know which vasti is better with respect to gut microbiome i.e Takravasti that contains takra where takra is a natural probiotic that replenishes the intestinal flora or SaṅgraÌ„hi vasti that does not contain takra. 8 participants satisfying diagnostic and inclusion criteria will be taken for study. Extracted DNA samples from the stool will be subjected to 16S rRNA sequencing to know the modulations in gut microbiome. Assessments will be done before the first day of vasti and the next day after last vasti. Data will be collected and will be analysed using relevant statistical tests. The outcome will be submitted in the form of dissertation.

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 50.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Participants presenting with clinical features of Irritable Bowel syndrome Participants of either sex between the age group of 18-50 years Participants who are fit for Vasti procedure.

Exclusion Criteria

  • Participants with known case of Inflammatory bowel disorders which includes Crohn’s disease and Ulcerative Colitis, acute conditions like Cholera, Gastroenteritis Diagnosed case of uncontrolled Diabetes mellitus and hypertension Recent use of Antibiotics less than 3 months Anti-epileptic users Participants taking Iron supplements Alarm features of IBS Age less than 50 years, male gender, weight loss, nocturnal symptoms, family history of Colon Cancer, Anemia, Rectal bleeding.

Outcomes

Primary Outcomes

Modulation in gut microbiome

Time Frame: Baseline | 11th day

Secondary Outcomes

  • IBS Symptom Severity(Baseline & 11th day)

Investigators

Sponsor
Vaidyaratnam PS Varier Ayurveda College
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Fathima Moidoo

Vaidyaratnam PS Varier Ayurveda College Kottakkal

Study Sites (1)

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