CTRI/2025/07/090974 [Registered on: 16/07/2025] Trial Registered Prospectively
Last Modified On:
16/07/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Ayurveda
Study Design
Randomized, Parallel Group Trial
Public Title of Study
Clinical study on CaFi Tablets in elderly people with irregular bowel habits.
Scientific Title of Study
A Clinical study to evaluate efficacy and safety of CaFi Tablets (Cassia Fistula Extract) in the Management of Functional Constipation and Irregular Bowel Habit in Geriatric Population - An Open Labeled, Randomized, Comparative, Multi centric, Interventional, Prospective, Clinical Study.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
TIMER/CAFI-F/FC/2025/1, Version 1.0, 04th May 2025
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Narendra Mundhe
Designation
Assistant Professor
Affiliation
KVTR Ayurvedic College and Hospital, Boradi
Address
KVTR Ayurvedic College and Hospital Department of Kayachikitsa, OPD No 5, Ground Floor, KVTR Ayurvedic College and Hospital, Boradi, Tal. Shirpur, Dist. Dhule
Dhule MAHARASHTRA 425428 India
Phone
9850378206
Fax
Email
drnbmundhe@gmail.com
Details of Contact Person Scientific Query
Name
Dr Sanjay Tamoli
Designation
Director
Affiliation
Target Institute of Medical Education and Research Pvt Ltd
Address
Target Institute of Medical Education and Research Pvt Ltd
A wing 402 A, B, C, Jaswanti Allied Business Centre,
Ramchandra Lane Extension,
Kachpada, Malad West, Mumbai
Mumbai (Suburban) MAHARASHTRA 400064 India
Phone
9322522252
Fax
Email
targetinstitute@yahoo.com
Details of Contact Person Public Query
Name
Dr Sanjay Tamoli
Designation
Director
Affiliation
Target Institute of Medical Education and Research Pvt Ltd
Address
Target Institute of Medical Education and Research Pvt Ltd
A wing 402 A, B, C, Jaswanti Allied Business Centre,
Ramchandra Lane Extension,
Kachpada, Malad West, Mumbai
MAHARASHTRA 400064 India
Phone
9322522252
Fax
Email
targetinstitute@yahoo.com
Source of Monetary or Material Support
Target Institute of Medical Education and Research Pvt Ltd
A wing 402 A, B, C, Jaswanti Allied Business Centre,
Ramchandra Lane Extension,
Kachpada, Malad West, Mumbai 400064
Primary Sponsor
Name
Target Institute of Medical Education and Research Pvt Ltd
Address
A wing 402 A, B, C, Jaswanti Allied Business Centre,
Ramchandra Lane Extension,
Kachpada, Malad West, Mumbai 400064
Type of Sponsor
Contract research organization
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 2
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Shishir P Pande
Ayurved Seva Sanghs Ayurved Mahavidyalaya. Ganeshwadi Panchavati Nashik
Department of Rasshastra and Bhaishajya Kalpana, OPD No 9, Ground floor, Ayurved Seva Sanghs Ayurved Mahavidyalaya. Ganeshwadi Panchavati Nashik -422003
Nashik MAHARASHTRA
9420830818
shishir.nsk@gmail.com
Dr Narendra Mundhe
KVTR Ayurvedic College and Hospital Boradi
Department of Kayachikitsa, OPD No 5, Ground Floor,
KVTR Ayurvedic College and Hospital, Boradi,
Tal. Shirpur, Dist. Dhule 425428
Dhule MAHARASHTRA
9850378206
drnbmundhe@gmail.com
Details of Ethics Committee
No of Ethics Committees= 2
Name of Committee
Approval Status
Institutional Ethics Committee, Ayurved Seva Sangh Ayurvedic College & Hospital, Ganeshwadi, Panchavati, Nashik
Submittted/Under Review
Institutional Ethics Committee, KVTR. Ayurved College & Hospital, Boradi
(1) Medicine Name: CaFi Tablet, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 250(mg), Frequency: hs, Bhaishajya Kal: Samudga, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: Subjects in CaFi tablet group will be given one Tablet of 250 mg of CaFi at bedtime with water for 14 days. All the subjects will be asked to stop given medication after 14 days and will be followed for next seven days to observe recurrence of symptoms of functional constipation and irregular bowel habit.
2
Comparator Arm
Drug
Other than Classical
(1) Medicine Name: Senna Extract Tablet, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 250(mg), Frequency: hs, Bhaishajya Kal: Samudga, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: . Subjects in Senna tablet group will be given one Tablet of 250 mg of Senna at bedtime with water for 14 days. All the subjects will be asked to stop given medication after 14 days and will be followed for next seven days to observe recurrence of symptoms of functional constipation and irregular bowel habit.
Inclusion Criteria
Age From
60.00 Year(s)
Age To
80.00 Year(s)
Gender
Both
Details
1. Subjects presenting with two or more of the following for the last 3 months with symptom onset at least 6 months prior to diagnosis:
a). Straining during more than one fourth (25 percent) of defecations
b). Lumpy or hard stools (Bristol Stool Form Scale 1-2) more than one fourth (25 percent) of defecations
c). Sensation of incomplete evacuation more than one fourth (25 percent) of defecations
d). Sensation of anorectal obstruction/blockage more than one fourth (25 percent) of defecations
e). Manual maneuvers to facilitate more than one fourth (25 percent) of defecations (e.g., digital evacuation, support of the pelvic floor)
f). Fewer than three SBM per week
g). Loose stools are rarely present without the use of laxative
h). Insufficient criteria for irritable bowel syndrome
2. Subjects who are ready to provide written informed consent and who are ready to willingly participate and follow the protocol requirements of the clinical study.
(The Rome IV diagnostic criteria for Functional constipation, 2016)
ExclusionCriteria
Details
1. Subjects diagnosed with colonic inertia.
2. Subjects who have recently undergone abdominal surgery
3. Subjects with history of anorectal surgery.
4.Subjects having other functional gastrointestinal disorders other than Functional constipation (i.e., IBS, Belching disorders etc.)
5. Subjects diagnosed with structural abnormalities, like:
i. Anorectal: rectal prolapse, rectocele, rectal intussusceptions, anorectal stricture, solitary rectal ulcer syndrome
ii. Perineal descent
iii. Colonic and rectal mass or tumor with obstruction e.g., adenocarcinoma
iv. Colonic stricture: radiation, ischemia, diverticulosis
v. Intestinal obstruction
6. Subjects with uncontrolled DM and hypertension and Tuberculosis.
7. Known cases of HIV, tuberculosis, hypo and hyperthyroidism
8. Known cases of renal or liver dysfunction.
9. Subjects diagnosed with neurological problems like,
i. Parkinson’s disease
ii. Multiple sclerosis
iii. Sacral nerve damage (prior pelvic surgery, tumor)
iv. Paraplegia
v. Autonomic neuropathy
10. Subjects on chronic medication (greater than 60 days) and or who are on medications known to cause constipation.
11. Pregnant or lactating females
12. Subjects allergic or atopic to any of the ingredients of the study medications
13. Other conditions, which in the opinion of the investigators makes the patient unsuitable for enrolment or could interfere in adherence to of the study protocol.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Change in frequency of bowel movements
screening visit, baseline visit, day 7, day 14 and day 21
Secondary Outcome
Outcome
TimePoints
1. Change in stool form using graded scale
2. Changes in symptoms of functional constipation including straining on defecation, sensation of incomplete evacuation, sensation of ano-rectal blockage, manual maneuvers required & average time spent for bowel evacuation
3. Changes in associated clinical symptoms including headache, belching, flatulence, abdominal distension, bloating, acidity on graded scale
4. Global assessment of overall change as per the investigator and subject
5. Assessment of tolerability of study product as per the investigator and subject by assessing Adverse Events, Adverse Reactions
6. Assessment of laboratory investigations such as Blood sugar fasting, Liver profile (SGOT, SGPT, Sr. Bilirubin) and Renal Profile (Sr. Creatinine)
screening visit, baseline visit, day 7, day 14 and day 21
Target Sample Size
Total Sample Size="100" Sample Size from India="100" 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 2/ Phase 3
Date of First Enrollment (India)
31/07/2025
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="6" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Open to Recruitment
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
It is a clinical study to evaluate efficacy and safety of CaFi Tablets
(Cassia Fistula Extract) in the Management of Functional Constipation and
Irregular Bowel Habit in Geriatric Population - An Open Labeled, Randomized,
Comparative, Multi centric, Interventional, Prospective, Clinical Study. The
study will be conducted in 2 to 3 centres in India. As per computer generated randomization
list, subjects will be randomized either to CaFi tablet group or Senna extract
tablet group in 1:1 ratio. Subjects in CaFi tablet
group will be given one Tablet of 250 mg of CaFi at bedtime with water for 14
days. Subjects in Senna tablet group will be given one Tablet of 250 mg of Senna
at bedtime with water for 14 days. All the subjects will be asked to stop given
medication after 14 days and will be followed for next seven days to observe
recurrence of symptoms of functional constipation and irregular bowel habit.
The primary objective of the study will be to assess change in frequency of
bowel movements. The secondary objectives of the study will be to assess change
in stool form using graded scale, changes in symptoms of functional
constipation including straining on defecation, sensation of incomplete
evacuation, sensation of ano-rectal blockage, manual manoeuvres required &
average time spent for bowel evacuation, changes in associated clinical
symptoms including headache, belching, flatulence, abdominal distension, bloating,
acidity on graded scale, global assessment of overall change as per the
investigator and subject, tolerability of study product as per the investigator
and subject by assessing Adverse Events, Adverse Reactions, and laboratory
investigations such as Blood sugar fasting, Liver profile (SGOT, SGPT, Sr.
Bilirubin) and Renal Profile (Sr. Creatinine) on screening visit, baseline
visit, day 7, day 14 and day 21