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CTRI Number  CTRI/2024/04/066414 [Registered on: 26/04/2024] Trial Registered Prospectively
Last Modified On: 26/09/2024
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Ayurveda
Siddha
Diagnostic 
Study Design  Single Arm Study 
Public Title of Study   To Assess Efficacy and Safety of Eyingkuttu Pattai in Patients with Functional Constipation  
Scientific Title of Study   A Single Center, Single Arm, Pilot Study Assessing Efficacy and Safety of Herbal Powder in Patients with Functional Constipation.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
SMM-EKP-001-23,Version 1, 31-Dec-2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr S Chikkalingaiah 
Designation  Principal Investigator 
Affiliation  Medstar Speciality Hospital 
Address  641 17 1 3 Kodigehalli Main road Sahakar Nagar Bengaluru

Bangalore
KARNATAKA
560092
India 
Phone  8248599949  
Fax    
Email  drchikkalingaiahmedstar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Yogesh Sharma  
Designation  Director Medical Affairs 
Affiliation  iDD Research Solutions Pvt Ltd 
Address  12 A First Floor 3rd Sector HSR Layout Bengaluru, Karnataka - 560102

Bangalore
KARNATAKA
560102
India 
Phone  8919832152  
Fax    
Email  yogesh@iddresearch.com  
 
Details of Contact Person
Public Query  
Name  Brindha Arumugam 
Designation  Project Manager 
Affiliation  iDD Research Solutions Pvt Ltd 
Address  12 A First Floor 3rd Sector HSR Layout Bengaluru, Karnataka - 560102

Bangalore
KARNATAKA
560102
India 
Phone  9894514883  
Fax    
Email  brindha.arumugam@iddresearch.com  
 
Source of Monetary or Material Support  
Sri Karumalaiyaan Mooligai SKM Thottam Perumpallam Dam Kembanaickenpalayam Sathyamangangalam Erode 
 
Primary Sponsor  
Name  Sri Karumalaiyaan Mooligai 
Address  Sri Karumalaiyaan Mooligai SKM Thottam Perumpallam Dam Kembanaickenpalayam Sathyamangangalam Erode 
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 S Chikkalingaiah  Medstar Speciality Hospital  641 17 1 3 , Gastero enterology Department, Kodigehalli Main road Sahakar Nagar Bengaluru
Bangalore
KARNATAKA 		 8248599949
-
drchikkalingaiahmedstar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Medstar Speciality Hospital Ethics Commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K590||Constipation. Ayurveda Condition: VIBANDHA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: EyingkuttuPattai(Herbal powder), Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -), Additional Information: Burkill IH. A Dictionary of the Economic Products of Malay Peninsular. Ministry of Agriculture of Malaysia; 1935.
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Male/Female participants ≥18 years of age at the time of consent
1. Participants with loose stool being rarely present without the use of laxatives
2. Participants with insufficient criteria for irritable bowel syndrome
3. Participants presenting with two or more of the following for the last three months with symptom onset at least six months prior to diagnosis:
(a) Straining during at least 25% of defecations (b) Lumpy or hard stools at least 25% of defecations (c) Sensation of incomplete evacuation at least 25% of defecations (d) Sensation of anorectal obstruction/blockage at least 25% of defecations (e) Manual maneuvers to facilitate at least 25% of defecations, eg: digital evacuation, support of the pelvic floor (f) Fewer than three defecations per week and those in whom loose stools were rarely present without the use of laxatives]
4. Female participant of non-childbearing potential, including any female who: a) has had a hysterectomy, b) has had a bilateral oophorectomy, c) has had a bilateral tubal ligation or d) is post-menopausal (demonstration of total cessation of menses for ≥ 1 year from the date of the screening visit)
5. Female participants of childbearing potential who agree to use two forms of contraception, one of which must be a barrier method, during the full duration of the study
6. Participants with a stool form score ranging from 1 to 3 on the “Bristol Stool Form Scale"
7. Participants/ Legally Acceptable Representative who are willing to provide written Informed Consent and comply with study procedures 
 
ExclusionCriteria 
Details  1 Participants with obstructive disorders and neurologic problems
2 Participants taking concomitant medications which are known to cause constipation like opioid analgesics, antidepressants, i.e., amitriptyline and imipramine, anticonvulsants, and aluminum-containing antacids)
3 Participants on chronic laxative medication(Greater than 60 days)
4 Participants with IBS, Belching disorders, etc. participants with a history of abdominal or anorectal surgery in the past one year and those with renal or liver dysfunction or colonic inertia or structural abnormalities of gastro-intestinal tract or uncontrolled systemic ailments (like Human immunodeficiency virus, Diabetes mellitus, and Tuberculosis) or neurological problems (like Parkinson’s disease, multiple sclerosis, sacral nerve damage, and paraplegia or autonomic neuropathy)
5 Participants who are allergic to any of the ingredients of the investigational product
6 Pregnant and female lactating women at the time of screening
7 Participants with any condition which makes the subject unsuitable for study participation which as per the investigator would jeopardize the outcome of the trial or participant who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Changes in frequency of bowel movements and changes in stool form assessed using the “Bristol stool form scale.  Day 1,Day 7,Day 15. 
 
Secondary Outcome  
Outcome  TimePoints 
1. a. Changes in the following symptoms:
- straining on defecation
- sensation of incomplete evacuation
- sensation of anorectal blockage
- manual maneuvers required
- average time spent for bowel evacuation
b. Overall/global improvement (by subject and investigator) on 4-point scale.

2. Number of Treatment Emergent Adverse Event (TEAE) and Treatment Emergent Serious Adverse Event (TESAE). 		 Day 1,Day 7,Day 15. 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   07/05/2024 
Date of Study Completion (India) 28/06/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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   Constipation is a common gastrointestinal complaint in apparently healthy populations as well as in patients with various predisposing disorders. Functional constipation can be caused by lifestyle factors, psychological factors and behavioural factors; withholding behaviour is a key factor in the Pathophysiology of childhood functional constipation, whereas adults often have dyssynergic defaecation patterns.
Factors involved in constipation include low fiber diet, caffeine abuse, overuse of alcohol, medications, endocrine disorders (hypothyroid), neurologic disease (neuropathy) and psychological issues.
A comprehensive medical history and physical examination are the foundation for the diagnosis of functional constipation; further testing is only necessary if alarming symptoms are present or conventional treatments are unsuccessful.
Anorectal malformations, pelvic/rectal masses, rectal prolapse, rectocele, dysfunctional voiding, pelvic floor dyssynergia, internal anal sphincter hypertonicity, and achalasia should all be ruled out before functional constipation is diagnosed. Hirschsprung disease and visceral myopathies or neuropathies should both be ruled out as colorectal diseases.
Colorectal conditions should be ruled out, including visceral myopathies or neuropathies, as well as Hirschsprung disease. Systemic conditions, psychosocial issues, drugs or toxins need to be identified.
The Pathophysiology underlying functional constipation is multifactorial and not well understood. Factors that may contribute to functional constipation include pain, fever, dehydration, dietary and fluid intake, psychological issues, toilet training, medicines, and family history of constipation.
 
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