| CTRI Number |
CTRI/2024/12/078473 [Registered on: 23/12/2024] Trial Registered Prospectively |
| Last Modified On: |
06/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Comparing the effect of enema in patients with Irritable Bowel Syndrome |
|
Scientific Title of Study
|
A Comparative Clinical Trial on Efficacy of Takravasti and Sangrahi vasti done as Kalavasti in modulating Gut microbiome in 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 |
Dr Fathima Moidoo |
| Designation |
PG Scholar |
| Affiliation |
Vaidyaratnam PS Varier Ayurveda College Kottakkal |
| Address |
Department of Panchakarma
Vaidyaratnam PS Varier Ayurveda College Kottakkal
Edarikode PO
Malappuram
Malappuram KERALA 676501 India |
| Phone |
9645338335 |
| Fax |
|
| Email |
fathimamoidooshaikh@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Binitha A |
| Designation |
Professor |
| Affiliation |
Vaidyaratnam PS Varier Ayurveda College Kottakkal |
| Address |
Department of Panchakarma
Vaidyaratnam PS Varier Ayurveda College Kottakkal
Edarikode PO
Malappuram
Malappuram KERALA 676501 India |
| Phone |
9895201635 |
| Fax |
|
| Email |
drbinithaunni@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Benil PB |
| Designation |
Professor and HOD |
| Affiliation |
Vaidyaratnam PS Varier Ayurveda College Kottakkal |
| Address |
Department of Agada tantra
Vaidyaratnam PS Varier Ayurveda College Kottakkal
Edarikode PO
Malappura
Malappuram KERALA 676501 India |
| Phone |
9037570955 |
| Fax |
|
| Email |
binilbharathan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vaidyaratnam PS Varier Ayurveda College
Kottakkal
Malappuram
Kerala
676501
India |
|
|
Primary Sponsor
|
| Name |
Vaidyaratnam PS Varier Ayurveda College |
| Address |
Department of Panchakarma
Vaidyaratnam PS Varier Ayurveda College Kottakkal
Edarikode PO
676501
Malappuram
Kerala
India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Fathima Moidoo |
Vaidyaratnam PS VarierAyurveda College Kottakkal |
OPD Department of Panchakarma Room number A112
Vaidyaratnam PS VarierAyurveda College Kottakkal
Edarikode PO
Malappuram Kerala
676501 Malappuram KERALA |
9645338335
fathimamoidooshaikh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(IEC)VAIDYARATNAM PS VARIER AYURVEDA COLLEGE KOTTAKKAL |
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:K582||Mixed irritable bowel syndrome. Ayurveda Condition: GRAHANI-PURVARUPAM, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | bastikarma/vastikarma, बसà¥à¤¤à¤¿à¤•रà¥à¤®/वसà¥à¤¤à¤¿à¤•रà¥à¤® | (Procedure Reference: Yadavaji thrikamji editors, SuÅ›hruta Samhita of SuÅ›hruta with the Nibandhasangraha commentary. 8th edition. Varanasi: Chaukhamba Orientalia; 2014, Chikitsa Sthaan 38/87; p.546, Procedure details: Stool will be collected before 1st day of vasti and after last vasti. DNA will be extracted from the stool sample and 16S rRNA sequencing will be done .) (1) Medicine Name: Madhu Saindhava lavaṇa Shatpala ghá¹›ta Ambaá¹£á¹hÄdi gaṇa kalka Priyangwadi gaṇa kashaya Takra, Reference: Yadavaji thrikamji editors, SuÅ›hruta Samhita of SuÅ›hruta with the Nibandhasangraha commentary. 8th edition. Varanasi: Chaukhamba Orientalia; 2014, Chikitsa Sthaan 38/87; p.546, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 800(ml), Frequency: od, Duration: 16 Days | | 2 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बसà¥à¤¤à¤¿à¤•रà¥à¤®/वसà¥à¤¤à¤¿à¤•रà¥à¤® | (Procedure Reference: Yadavaji thrikamji editors, SuÅ›hruta Samhita of SuÅ›hruta with the Nibandhasangraha commentary. 8th edition. Varanasi: Chaukhamba Orientalia; 2014, Chikitsa Sthaan 38/87; p.546, , Procedure details: Stool will be collected before 1st day of vasti & after last vasti. DNA will be extracted from the stool sample & 16S rRNA sequencing will be done) (1) Medicine Name: Madhu Saindhava lavaṇa Shatpala ghá¹›ta Ambaá¹£á¹hÄdi gaṇa kalka Priyangwadi gaṇa kashaya, Reference: Yadavaji thrikamji editors, SuÅ›hruta Samhita of SuÅ›hruta with the Nibandhasangraha commentary. 8th edition. Varanasi: Chaukhamba Orientalia; 2014, Chikitsa Sthaan 38/87; p.546,, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 800(ml), Frequency: od, Duration: 16 Days |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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
|
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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 |
| Modulation in gut microbiome |
Baseline
11th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| IBS Symptom Severity |
Baseline & 11th day |
|
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Target Sample Size
|
Total Sample Size="8" Sample Size from India="8"
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
|
N/A |
|
Date of First Enrollment (India)
|
23/12/2024 |
| 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" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
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 (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, SÌamanaosÌ£adhi, PathyaÌ„pathya etc. There is a reference of SaṅgraÌ„hi Vasti in SusÌrutasamÌ£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.
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