To Understand the Effect of Grahani Treatment Protocol on Gut Microbiota Flora in Irritable Bowel Syndrome- Mixed

Phase 3

Not yet recruiting

Conditions: Mixed irritable bowel syndrome. Ayurveda Condition: GRAHANIDOSHAH,

Brief Summary: 10 patients fulfilling the inclusion and exclusion criteria, who are voluntarily ready to participate will be selected from the OPD and IPD of Post-Graduate Department of Kayachikitsa, Amrita Ayurveda Hospital. For Pachana-Deepana, 50 ml of Vacharidradi Kashaya twice daily before food will be given for 3-7 days or till the attainment of Samyak Langhita Lakshanas, whichever is seen earlier. Then the patient will be subjected to Sadya Snehapana with Dadimadi Ghrita for 3 days. For the next 3 days the patient will be subjected to Sarvanga Abhyanga with Tila Taila and Bashpa Sweda. Virechana with Avipatti Churna along with Honey will be administered after Sarvanga Abhyanga Bashpa Sweda. This will be followed by Samsarjana Karma according to the Koshta Suddhi. After Virechana, Shamana Oushadha will be administered for the next 30 days with 6 grams of Priyanguambashtadhi churna along with Takra twice daily, orally before food. Post treatment assessment will be done after 30 days of Shamana Oushadha Prayoga by using Bristol stool form scale, IBS-SSS(symptom severity scale), VAS (visual anolog scale), IBS- Qol (quality of life scale) and Assessment of Gut Microbiota in stool sample. The data collected will be statistically evaluated

Recruitment & Eligibility

Inclusion Criteria

1. Participants fulfilling ROME IV CRITERIA 2. Age: 20.
45 years with no discrimination of sex, caste, religion and economic status 3. Patients identified with the presence of specific strains of Lactobacilli and Bifidobacteria from their fecal samples. 4. Participants from whom the written consent is obtained.

Exclusion Criteria

Those with the endoscopic findings of peptic ulcer or any organic lesions and other systemic disorders 2.
Those on NSAIDâ€™s in the last six months, antibiotics or other long-term and continuous medication 3.
Patients with alcohol dependency or drug dependency.
Pregnant women and lactating mothers.

Primary Outcome Measures

Name	Time	Method
1. Bristol Stool Form Scale (BSF)	1. Before intervention 0th day \| 2. After intervention approximately on 50th day
2. VAS (Visual Analog Scale)	1. Before intervention 0th day \| 2. After intervention approximately on 50th day
3. IBS- SSS (Symptom Rating Scale)	1. Before intervention 0th day \| 2. After intervention approximately on 50th day
4. IBS- QoL (Quality of Life) Questionnaire	1. Before intervention 0th day \| 2. After intervention approximately on 50th day
5. Assessment of the Gut Microbiota in the Stool sample (Before and after treatment)	1. Before intervention 0th day \| 2. After intervention approximately on 50th day

Secondary Outcome Measures

Name	Time	Method
Not Applicable	Not Applicable

Locations (1): Amrita Ayurveda Hospital
🇮🇳
Kollam, KERALA, India
Amrita Ayurveda Hospital
🇮🇳Kollam, KERALA, India
Dr Vijayarajaa P
Principal investigator
07598366065
vjrajaa@gmail.com