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CTRI Number  CTRI/2023/03/051094 [Registered on: 27/03/2023] Trial Registered Prospectively
Last Modified On: 30/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Clinical study of Softovac Liquifibre in constipation 
Scientific Title of Study   A Clinical study to evaluate efficacy and safety of Softovac Liquifibre in the Management of Functional Constipation and Irregular Bowel Habit-An Open Label, Randomized, Comparative, Multi centric, Interventional, Prospective, Clinical Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
SOFTOVAC/LUPIN/2023/1, Version 1.0, 28th Feb 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Narendra B Mundhe 
Designation  Assistant Professor  
Affiliation  KVTR Ayurvedic College and Hospital Boradi 
Address  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 Center, 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 Center, Ramchandra Lane Extension, Kachpada, Malad West, Mumbai


MAHARASHTRA
400064
India 
Phone  9322522252  
Fax    
Email  targetinstitute@yahoo.com  
 
Source of Monetary or Material Support  
Lupin Limited 3rd floor, Kalpataru Inspire Building, Opposite to Hotel Grand Hyatt, Santacruz east, Mumbai-400055  
 
Primary Sponsor  
Name  Lupin Limited 
Address  3rd floor, Kalpataru Inspire Building, Opposite to Hotel Grand Hyatt, Santacruz east, Mumbai-400055  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shishir Pande   Ayurved Seva Sangh’s Ayurved Mahavidyalaya  Ayurved Sanshodhan Vibhag, OPD No 9, Ground Floor, Ayurved Seva Sangh’s Ayurved Mahavidyalaya, Ganeshwadi, Panchvati, Nashik, Maharashtra – 422003
Nashik
MAHARASHTRA 		 9146030818

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 
Dr Pradnya Kapse  R. A. Podar Medical, College (Ayu), M. A. Podar Hospital  Department of Shalya Tantra, OPD No 10, Ground Floor, R. A. Podar Medical, College (Ayu), M. A. Podar Hospital, Worli, Mumbai-400018
Mumbai
MAHARASHTRA 		 9930939867

rasrajk@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Institutional Ethics Committee, Ayurved Seva Sangh Ayurved Mahavidyalaya, Nashik  Approved 
Institutional Ethics Committee, KTVR Ayurved College and Hospital, Boradi.  Approved 
Institutional Ethics Committee, R A Podar Medical College (Ayu), M.A.Podar Hospital, Worli Mumbai  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: Softovac Liquifibre , Reference: NA, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 5(ml), Frequency: hs, Bhaishajya Kal: Samudga, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: Cohort 2: Subjects will be given 5 to 10 ml Softovac Liquifibre 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
2Comparator Arm (Non Ayurveda)-Combination of Milk of magnesia and Liquid paraffinSubjects in this group will be given 10 ml of combination of milk of magnesia and Liquid paraffin at bedtime with water for 14 days
3Intervention ArmDrugOther than Classical(1) Medicine Name: Softovac Liquifibre, Reference: NA, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 20(ml), Frequency: hs, Bhaishajya Kal: Samudga, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: Cohort 1: Subjects in this group will be given 20 ml Softovac Liquifibre at bedtime with water for 14 days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Male or female subjects between the age group of 18 to 70 years (Cohort 1) and 6 to 15 years (Cohort 2)
Subjects diagnosed as per the Rome IV diagnostic criteria for Functional constipation, 2016 (Cohort 1) and ROME IV Criteria for Functional Constipation (H3a) (Cohort 2)
3. 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.
 
 
ExclusionCriteria 
Details  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 of intestine
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
10. Subjects on chronic medication (>60 days) and/or who are on medications known to cause constipation.
11. Pregnant or lactating females (Cohort 1)
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 
Cohort 1 and 2:
Change in frequency of bowel movements from baseline visit to the end of the study visit and between the two groups
 		 Screening visit, Day 0, Day 7, Day 14 and Day 21 
 
Secondary Outcome  
Outcome  TimePoints 
Cohort 1 and 2:
1. Change in stool form
2. Changes in symptoms of functional constipation
3. Changes in associated clinical symptoms of functional constipation
4. Average duration of action (from the time of consuming tablets to first bowel movement)
5. Global assessment of overall change as per the investigator and subject
6. Assessment of tolerability of study product as per the investigator and subject
7. Assessment of laboratory investigations (in cohort 1 only)
 		 Screening visit, Day 0, Day 7, Day 14 and Day 21 
 
Target Sample Size   Total Sample Size="108"
Sample Size from India="108" 
Final Enrollment numbers achieved (Total)= "102"
Final Enrollment numbers achieved (India)="102" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   31/03/2023 
Date of Study Completion (India) 02/09/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not Yet Done 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  		 It is an open label, randomized, comparative, multi centric, interventional, prospective, clinical study to evaluate efficacy and safety of Softovac Liquifibre in the management of functional constipation and Irregular Bowel Habit. The study will be carried out in two cohort. Cohort 1 will have adult population and cohort 2 will have children and teenagers. The study will be carried out at three to four centers in India. In cohort 1, subjects will be randomized to either Softovac Liquifibre group or milk of magnesia + Liquid paraffin group. Subjects in Softovac Liquifibre group will be given 20 ml Softovac Liquifibre at bedtime with water for 14 days and subjects in milk of magnesia + Liquid paraffin group will be given 10 ml of milk of magnesia + Liquid paraffin 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. In cohort 2, subjects will be given 5 to 10 ml Softovac Liquifibre 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. Primary objective of cohort 1 and 2 will be to assess change in frequency of bowel movements. Secondary objectives of cohort 1 and 2 will be to assess change in stool form, 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, changes in associated clinical symptoms including headache, belching, flatulence, abdominal distension/bloating, acidity, average duration of action (from the time of consuming tablets to first bowel movement), global assessment of overall change as per the investigator and subject, assessment of tolerability of study products as per the investigator and subject. Additionally in cohort 1, assessment of laboratory investigations such as CBC, ESR, Hb%, Blood sugar fasting, Liver profile and Renal Profile will be done. 

Summary of Results:

It can be concluded from the results of the study that Softovac Liquifibre was significantly effective in increasing frequency of bowel movements in adults and children suffering from functional constipation and irregular bowel habit. Softovac Liquifibre was significantly effective in softening stool, reliving straining on defecation, sensation of anorectal blockage and requirement of manual maneuvers in children and adults. Time spent for defecation was significantly reduced after usage of Softovac Liquifibre in adults and children. Symptoms associated with constipation, viz. headache, acidity, belching, flatulence, and abdominal bloating/distension significantly improved after usage of Softovac Liquifibre in adults and children. Symptoms and associated symptoms of functional constipation did not recur on day 21 after stoppage of treatment from day 14 onwards both in adults as well as in children suggesting non-habit-forming nature of Softovac Liquifibre. The results of the study also showed all parameters comparable (non significantly different) with current market leading formulation for functional constipation. Softovac Liquifibre can be recommended as a safe and effective remedy for functional constipation and irregular bowel habit in adults and children.
 
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