| CTRI Number |
CTRI/2021/12/039045 [Registered on: 30/12/2021] Trial Registered Prospectively |
| Last Modified On: |
29/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To Understand the Effect of Grahani Treatment Protocol on Gut Microbiota Flora in Irritable Bowel Syndrome- Mixed |
|
Scientific Title of Study
|
A Pre and Post Test Clinical Study to Evaluate the Effectiveness Of Grahani
Treatment Protocol on Gut Microbiota Flora in IBS- Mixed
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vijayarajaa P |
| Designation |
PG Scholar Department of Kayachikitsa |
| Affiliation |
Amrita School of Ayurveda |
| Address |
PG Scholar Department of Kayachikitsa Amrita School of Ayurveda Kollam Kerala
Kollam
KERALA
690525
India |
| Phone |
7598366065 |
| Fax |
|
| Email |
vjrajaa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Devipriya Soman |
| Designation |
Associate Professor Department of Kayachikitsa |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Associate Professor Department of Kayachikitsa Amrita School of Ayurveda Kollam Kerala
Kollam
KERALA
690525
India |
| Phone |
9495638076 |
| Fax |
|
| Email |
priya3656@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Devipriya Soman |
| Designation |
Associate Professor Department of Kayachikitsa |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Associate Professor Department of Kayachikitsa Amrita School of Ayurveda Kollam Kerala
Kollam
KERALA
690525
India |
| Phone |
9495638076 |
| Fax |
|
| Email |
priya3656@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita School of Ayurveda Clappana (PO) Kollam |
|
|
Primary Sponsor
|
| Name |
Dr Vijayarajaa P |
| Address |
PG Scholar Department of Kayachikitsa Amrita School of Ayurveda Kollam Kerala |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Vijayarajaa P |
Amrita Ayurveda Hospital |
Amrita School of
Ayurveda Department
of Kayachikitsa
Clappana (PO),
Vallikavu Pin 690525
Kollam
KERALA
Kollam
KERALA |
07598366065
vjrajaa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Amrita Institute of Medical Sciences |
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 | Drug | Classical | | (1) Medicine Name: Priyanguambashtadhi Gana Churna, Reference: Ashtanga Hridayam Sutrasthana Chapter 15; Shodanadigana Sangraha, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Takra), Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
1. Those with the endoscopic findings of peptic ulcer or any organic lesions
and other systemic disorders
2. Those on NSAID’s in the last six months, antibiotics or other long-term and
continuous medication
3. Patients with alcohol dependency or drug
dependency.
4. Pregnant women and lactating mothers |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Bristol Stool Form Scale (BSF)
2. VAS (Visual Analog Scale)
3. IBS- SSS (Symptom Rating Scale)
4. IBS- QoL (Quality of Life) Questionnaire
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
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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 3 |
|
Date of First Enrollment (India)
|
31/12/2021 |
| 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="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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 |