CTRI

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CTRI Number

CTRI/2025/01/079322 [Registered on: 23/01/2025] Trial Registered Prospectively

Last Modified On:

23/01/2025

Post Graduate Thesis

No

Type of Trial

Interventional

Type of Study

Ayurveda

Study Design

Single Arm Study

Public Title of Study

A pilot study to evaluate the efficacy and safety of Pankajakasthuri Daily Lax in subjects with constipation

Scientific Title of Study

A single arm clinical study to evaluate the efficacy and safety of Pankajakasthuri Daily Lax in improving bowel regularity of subjects with constipation

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 J Hareendran Nair
Designation	Managing Director and Founder
Affiliation	Pankajakasthuri Herbal Research Foundation
Address	Room No1 Department of E&D Pankajakasthuri Herbal Research Foundation Pankajakasthuri Ayurveda Medical college Kattakkada Thiruvananthapuram KERALA 695572 India
Phone
Fax
Email	hareendrannair@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Kasthuri Nair A
Designation	Director
Affiliation	Pankajakasthuri Ayurveda Medical college and PG centre
Address	Room No 1 Department of kayachikitsa Pankajakasthuri Ayurveda Medical college and PG centre Killy Thiruvananthapuram KERALA 695572 India
Phone	8113851665
Fax
Email	dr.kasthurinair@pkhil.com

Details of Contact Person
Public Query

Name	Dr Kasthuri Nair A
Designation	Director
Affiliation	Pankajakasthuri Ayurveda Medical college and PG centre
Address	Room No1 Department of kayachikitsa Pankajakasthuri Ayurveda Medical college and PG centre Killy Thiruvananthapuram KERALA 695572 India
Phone	8113851665
Fax
Email	dr.kasthurinair@pkhil.com

Source of Monetary or Material Support

Pankajakasthuri Herbals India Pvt Ltd Poovachal, Kerala, India-695575

Primary Sponsor

Name	Pankajakasthuri Herbals India Pvt Ltd
Address	Poovachal Trivandrum Kerala Pin: 695575
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 Sreejith Satheesan	Pankajakasthuri Ayurveda Medical college and PG centre	Room No 2 Department of Shalyatandra, Pankajakasthuri Ayurveda Medical college and PG centre Thiruvananthapuram Thiruvananthapuram KERALA Thiruvananthapuram KERALA	9447791353 dr.sreejith.satheesan@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Independent Ethics Committee of Pankajakasthuri Herbal Research Foundation	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:K63\|\|Other diseases of intestine. Ayurveda Condition: VIBANDHA,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Other than Classical		(1) Medicine Name: Daily lax, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: No, Additional Information: -

Inclusion Criteria

Age From	18.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	i. Subjects willing and able to provide signed informed consent prior to any study related to procedure. ii. Subjects of either sex in the age group between 18 to 60 years. iii. Participants with a confirmed diagnosis of constipation, defined as fewer than 3 bowel movements per week, or a history of straining, hard stools, or incomplete evacuation. iv. Participants who have used laxatives in the past, but have not used them in the 2 weeks prior to study entry.

ExclusionCriteria

Details

i. Women who are pregnant, lactating or planning to become pregnant during the study period.
ii Subjects with severe constipation, defined as fewer than 1 bowel movement per week.
iii. Subjects with symptoms of acute abdomen and intestinal obstruction.
iv. Subjects with a history of gastrointestinal conditions such as inflammatory bowel disease, tumours, gastrointestinal obstruction or gastrointestinal surgery.
v. Subjects with known hypersensitivity to ingredients of the trial drug.
vi. Subjects with History of Diabetes mellitus, hypertension, immunodeficiency or any illnesses that may be worsened by participation in the trial.
vii. Patients who, during the previous week, had ingested any drug that, in the opinion of the investigator, would have an effect on gastrointestinal motility
viii. Subjects with history of alcohol or drug abuse.
ix. Subjects participating in any other clinical trial.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
1. Frequency of Bowel movement per day 2. Consistency of bowel. 3. Subjective criteria (bloating, straining, incomplete evacuation).	Evaluation will be done on baseline (ie; 0th day), 7th day, 14th day, 21st day and 28th day (end of treatment). And follow-up 1 week post treatment (35th day).

Secondary Outcome

Outcome	TimePoints
1. Blood routine, LFT and RFT will be done to evaluate the safety of the trial drug before (0th day) and after the treatment (28th day). 2. Reporting and assessment of Adverse reactions / side effects if any. Adverse events, such as cramping and diarrhoea will be carefully monitored throughout the study.	valuation will be done on baseline (ie; 0th day and after the treatment (28th day).

Target Sample Size

Total Sample Size="30"
Sample Size from India="30"
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

Date of First Enrollment (India)

03/02/2025

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="3"
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

Title: A Pilot Study to Evaluate the Efficacy and Safety of Pankajakasthuri Daily Lax in Subjects with Constipation

Investigator/Trial Location: Pankajakasthuri Ayurveda Medical College & PG Centre, Killy, Kattakada, Thiruvananthapuram, Kerala

Study Objectives: This single-arm Phase 2 clinical trial aims to assess the efficacy of Pankajakasthuri Daily Lax in improving bowel regularity and its safety profile in subjects suffering from constipation.

Study Design: An open-label clinical trial without a control group.

Study Population: Male and female subjects aged 18 to 60 years diagnosed with constipation (defined as fewer than 3 bowel movements per week or history of straining, hard stools, or incomplete evacuation).

Main Inclusion Criteria: Subjects willing to provide informed consent, not currently using laxatives, and meeting the criteria for constipation diagnosis.

Main Exclusion Criteria: Subjects with severe constipation, acute abdominal symptoms, gastrointestinal disorders, hypersensitivity to trial drug ingredients, or concurrent participation in other clinical trials.

Expected Number of Subjects: 30

Investigational Product: Pankajakasthuri Daily Lax, administered orally.

Duration of Experiment: 4 weeks

Assessment Criteria: Frequency and consistency of bowel movements, subjective symptoms (bloating, straining, incomplete evacuation), safety parameters (blood routine, LFT, RFT), and adverse reactions.

Assessment Schedule: Baseline (0th day), 7th, 14th, 21st, and 28th days (end of treatment), with a follow-up assessment on the 35th day.

Statistical Considerations: Appropriate statistical analysis will be performed to evaluate efficacy endpoints.

Conclusion: This study seeks to provide valuable insights into the potential of Pankajakasthuri Daily Lax as a safe and effective treatment option for constipation, addressing a common gastrointestinal issue that significantly impacts patient quality of life.