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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  
Name  Address 
NIL  NIL 
 
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 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K582||Mixed irritable bowel syndrome. Ayurveda Condition: GRAHANI-PURVARUPAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: Yadavaji thrikamji editors, Suśhruta Samhita of Suśhruta 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 ghṛta Ambaṣṭhādi gaṇa kalka Priyangwadi gaṇa kashaya Takra, Reference: Yadavaji thrikamji editors, Suśhruta Samhita of Suśhruta 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
2Intervention ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: Yadavaji thrikamji editors, Suśhruta Samhita of Suśhruta 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 ghṛta Ambaṣṭhādi gaṇa kalka Priyangwadi gaṇa kashaya, Reference: Yadavaji thrikamji editors, Suśhruta Samhita of Suśhruta 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
 
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
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Modulation in gut microbiome   Baseline
11th day 
 
Secondary Outcome  
Outcome  TimePoints 
IBS Symptom Severity   Baseline & 11th day 
 
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
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 IBSThe treatment principle in AÌ„yurveda consists of DiÌ„panaPaÌ„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.

 
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