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CTRI Number  CTRI/2025/02/081189 [Registered on: 24/02/2025] Trial Registered Prospectively
Last Modified On: 21/03/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Evaluation of Kayam Churna, Kayam Tablet, and Advance Kayam Granules for Constipation Relief and Digestive Health 
Scientific Title of Study   Clinical validation of the efficacy of Kayam Churna and Kayam Tablet and Advance Kayam Granules in managing functional constipation and related digestive parameters. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
MHC/CT/24-25/051 Version: 1.00; Dated, 09 January 2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ninad Naik  
Designation  Principal Investigator 
Affiliation  Lokmanya Medical Research Centre and Hospital 
Address  4th Floor OPD 401-314 Telco Road Chinchwad, Pune

Pune
MAHARASHTRA
411033
India 
Phone  9422089260  
Fax  -  
Email  naikninaad@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mr Malav Andharia 
Designation  Management Representative & Executive of Quality Assurance, 
Affiliation  Sheth Brothers 
Address  19,20,30,31, Vitthalwadi G.I.D.C., Bhavnagar Gujarat, India.

Bhavnagar
GUJARAT
364001
India 
Phone  9909227908  
Fax  -  
Email  malavctri@gmail.com  
 
Details of Contact Person
Public Query  
Name  Mr Gaurav Sheth and others  
Designation  Owner and Partners 
Affiliation  Sheth Brothers 
Address  19,20,30,31, Vitthalwadi G.I.D.C., Bhavnagar Gujarat, India.

Bhavnagar
GUJARAT
364001
India 
Phone  02782420807  
Fax  -  
Email  mr.gauravsheth1111@gmail.com  
 
Source of Monetary or Material Support  
Sheth Brothers 19,20,30,31, Vitthalwadi G.I.D.C., Bhavnagar-364001, Gujarat, India. 
 
Primary Sponsor  
Name  Sheth Brothers  
Address  19,20,30,31, Vitthalwadi G.I.D.C., Bhavnagar-364001, Gujarat, India. 
Type of Sponsor  Other [Ayush Industries ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sandip Vasant Jagtap  Ayushri Multispeciality Hospital   Samadhan Chowk Pimprigaon Pimpri,Pune-411017,Maharashtra, India Pune MAHARASHTRA
Pune
MAHARASHTRA 		 9604270042
-
drsandip.ayushrihospital@gmail.com 
Dr Ninad Naik  Lokmanya Medical Research Centre and Hospital  4th Floor OPD 401-314 Telco Road Chinchwad, Pune
Pune
MAHARASHTRA 		 9422089260
-
naikninaad@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee Lokmanya Medical Research Centre  Approved 
Institutional Ethics Committee Sangvi Multispeciality Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K590||Constipation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Advance Kayam Granules   Take 3–5 grams orally at bedtime with water for 30 days. 
Intervention  Kayam Churna   Take 3–5 grams orally at bedtime with water for 30 days. 
Intervention  Kayam Tablets   1 to 2 tablets to be taken with water at bedtime daily for 30 days. 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Males and Females between 30-60 years of age (both inclusive);
2. Participants agreeing with two or more of the following complaints for the last 3 months:
a) Straining during at least 25% of defecations:
b) Lumpy or hard stools at least 25% of defecations:
c) Sensation of incomplete evacuation of 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 e.g., digital evacuation, and support of the pelvic floor:
f) Fewer than three defecations per week;
3. Participants in whom loose stools are rarely present without the use of laxatives;
4. Participants having stool form between 1 to 3 on the Bristol Stool Form Scale;
5. Participants willing and able to provide signed informed consent form prior to any study related procedures;
6. Participants having hyperacidity;
7. Participants having gases and indigestion;
8. Participants having headaches induced by gases;
9. Comorbid participants on stable medication for the last three months, with no worsening of symptoms and/or need for hospitalization; can be enrolled in the study at per discretion of the
investigator. 
 
ExclusionCriteria 
Details  1. Participants with diagnosed colonic inertia;
2. Participants who have recently undergone abdominal surgery;
3. Participants with a history of anorectal surgery;
4. Participants having functional gastrointestinal disorders other than functional constipation i.e. IBS, Belching disorders, etc;
5. Participants diagnosed with structural abnormalities, like anorectal: rectal prolapse, rectocele, rectal intussusceptions, anorectal stricture, solitary rectal ulcer syndrome, perineal descent, colonic or rectal mass or tumor with obstruction e.g. adenocarcinoma, colonic stricture: radiation, ischemia, diverticulosis intestinal obstruction;
6. Participants with serious uncontrolled & diagnosed systemic ailments like HIV, DM and Tuberculosis;
7. Participants with renal or liver dysfunction;
8. Participants with diagnosed neurological problems like, parkinson’s disease, multiple sclerosis, sacral nerve damage for example prior pelvic surgery, tumor, and paraplegia;
9. Pregnant or lactating women.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Assessment of change in the frequency of bowel movements using a bowel diary will be done at screening, day 1, day 7, day 15, and day 30.
2.Assessment of change in stool form assessed by the Bristol Stool Form Scale using bowel diary will be done at screening, day 1, day 7, day 15, and day 30.
3.Assessment of change in other symptoms of functional constipation (e.g., straining on defecation, sensation of incomplete evacuation, sensation of anorectal blockage, manual maneuvers required, and average time spent for bowel evacuation) using a Visual Analog Scale (VAS) will be done at screening, day 1, day 7, day 15, and day 30.
 		 screening, day 1, day 7, day 15, and day 30. 
 
Secondary Outcome  
Outcome  TimePoints 
1.Assessment of change in abdominal bloating, gas, acidity, indigestion, and gas-induced headaches using the Modified Gastrointestinal Symptom Rating Scale (GSRS) will be done at screening, day 1, day 7, day 15, and day 30.
2.Global assessment for overall improvement by the investigator and patient using a 4-point scale will be done on day 15 and day 30.
 		 screening, day 1, day 7, day 15, and day 30. 
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
Final Enrollment numbers achieved (Total)= "180"
Final Enrollment numbers achieved (India)="180" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   07/03/2025 
Date of Study Completion (India) 30/04/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   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  

Functional constipation is a common and often distressing gastrointestinal condition characterized by infrequent or difficult bowel movements. While various treatments exist, the search for safe and effective therapies continues. Traditional Ayurvedic formulations, such as ’Kayam Churna’, ’Kayam Tablet’, and ’Advance Kayam Granules’, have been used in traditional Indian medicine to address digestive issues, including constipation. However, their clinical efficacy and safety in managing this condition require rigorous scientific investigation.

This study aims to systematically evaluate the clinical efficacy of these Ayurvedic formulations in improving bowel movement frequency, consistency, and overall constipation symptoms. It will assess their impact on various digestive parameters, such as stool consistency, abdominal pain, bloating, and quality of life. Furthermore, the study will meticulously monitor for any adverse events or side effects to determine the safety and tolerability of these formulations.

By conducting this rigorous clinical validation, the study aims to generate robust scientific evidence to support or refute the traditional claims of these Ayurvedic formulations in managing functional constipation. This evidence will be invaluable for healthcare professionals and patients in making informed decisions regarding the use of these traditional therapies for this prevalent condition.

In conclusion, this study is crucial in bridging the gap between traditional medicine and modern scientific evidence. It will provide valuable insights into the efficacy of these Ayurvedic formulations, potentially offering a safe and effective alternative or adjunct therapy for individuals suffering from functional constipation with digestive health.

 

 
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