| CTRI Number |
CTRI/2024/12/078288 [Registered on: 18/12/2024] Trial Registered Prospectively |
| Last Modified On: |
18/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Clinical trial to evaluate the combined efficacy of Zandu Kutaja Ghana Vati and Zandu Mugdha Rasa in the management of Atisara(Functional Diarrheoa) |
|
Scientific Title of Study
|
An open label double arm randomized controlled comparative Clinical Trial to evaluate the safety & effectiveness of Zandu Kutaja Ghana Vati in comparison to Zandu Kutaja Ghana Vati along with Zandu Mugdha Rasa in the management of Atisara |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rijin Mohan |
| Designation |
Assistant Professor |
| Affiliation |
Shri Dhanwantry Ayurvedic College and Hospital, Sector 46-B, Chandigarh |
| Address |
Dept of Roga Nidana, Shri Dhanwantry Ayurvedic College and Hospital, Sector 46-B, Chandigarh
Dept of Roga Nidana, Shri Dhanwantry Ayurvedic College and Hospital, Sector 46-B, Chandigarh
Chandigarh
CHANDIGARH
160047
India |
| Phone |
09496463399 |
| Fax |
|
| Email |
drrijinm@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sumit Srivastava |
| Designation |
Professor and Dean |
| Affiliation |
Shri Dhanwantry Ayurvedic College and Hospital, Sector 46-B, Chandigarh |
| Address |
Dept of Roga Nidana, Shri Dhanwantry Ayurvedic College and Hospital, Sector 46-B, Chandigarh
Kayachikitsa OPD and Research OPD (Room no 109)
Chandigarh
CHANDIGARH
Dr Sumit Srivastava
India |
| Phone |
09781110780 |
| Fax |
|
| Email |
sumitpankaj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumit Srivastava |
| Designation |
Professor and Dean |
| Affiliation |
Shri Dhanwantry Ayurvedic College and Hospital, Sector 46-B, Chandigarh |
| Address |
Dept of Roga Nidana, Shri Dhanwantry Ayurvedic College and Hospital, Sector 46-B, Chandigarh
Kayachikitsa OPD and Research OPD (Room no 109)
CHANDIGARH
Dr Sumit Srivastava
India |
| Phone |
09781110780 |
| Fax |
|
| Email |
sumitpankaj@gmail.com |
|
|
Source of Monetary or Material Support
|
| Emami Pvt Ltd, 13, Barrackpore Trunk Rd, Rathtala, Santhi Nagra Colony, Belghoria, Kolkata, West Bengal 700058 |
|
|
Primary Sponsor
|
| Name |
Emami Pvt Ltd |
| Address |
Emami Pvt Ltd,13, Barrackpore Trunk Rd, Rathtala, Santhi Nagra Colony, Belghoria, Kolkata, West Bengal 700058 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rijin Mohan |
Shri Dhanwantry Ayurvedic College and Hospital, Sector 46-B, Chandigarh |
Room no 109, Kayachikitsa OPD and Research OPD
Chandigarh
CHANDIGARH |
9496463399
drrijinm@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC SHRI DHANWANTRY AYURVEDIC COLLEGE AND HOSPITAL SECTOR 46-B, CHANDIGARH |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K928||Other specified diseases of the digestive system. Ayurveda Condition: ATISARAH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Zandu Kutaja Ghana vati and Zandu Mugdha Rasa,, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 3(NA), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: 2 Zandu Kutaja Ghana vati and 1 Zandu Mugdha Rasa will be administered twice daily | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Zandu Kutaja Ghana Vati, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 2(NA), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: 2 tablets of Zandu Kutaja Ghana Vati will be administered twice daily |
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Clinical presentation of Functional Diarrheoa symptoms
Patients with Atisara lakshana
Patients with either sex, 18 to 60 years age
All patients must agree not to share medication
Patients willing to participate and sign an informed consent
Understands and agrees to comply with planned study procedures
Agrees to provide sample for testing as per protocol
|
|
| ExclusionCriteria |
| Details |
Chronic, Severe, Unstable, Uncontrolled co-existent Medical illness such as Diabetes, Hypertension, Cardiac disorders, liver, kidney disorders and lung Disorders or other disease of concern which may put the patient at increased risk during the study
Active cancer diagnosis, on palliative treatment or requiring current therapy with antimetabolic agents, immunotherapy or radiotherapy.
Patients on parenteral nutrition
Patients with known sensitivity or contraindication to any of the ingredients of study medication
History of bleeding haemorrhoids, haemoptysis, acid peptic diseases, ulcers and pulmonary diseases (tuberculosis, asthma, etc.)
Pregnancy and lactation
Participation in a drug interventional clinical drug trial of any nature in the three month period
Patients who are either on Allopathy medicines or on other AYUSH medications
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Trial drug Zandu Mugdha Rasa 1 tablet and Zandu Kutaja Ghana Vati 2 tablets twice daily regularly after meals along with luke warm water may be effective in managing the symptoms as per Rome IV Criteria for Functional Diarrheoa and significant changes may be noted in parameters like LFT, RFT andLipid profile |
Day 1 and Day 7 |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| The Trial drug is effective in managing symptoms of Functional Diarrhea with respect to laboratory parameters |
Day 1 and Day 7 |
|
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Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
29/12/2024 |
| 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)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
An open label double arm randomized controlled comparative Clinical Trial to evaluate the safety & effectiveness of Zandu Kutaja Ghana Vati in comparison to Zandu Kutaja Ghana Vati along with Zandu Mugdha Rasa in the management of Atisara
Introduction: Functional diarrhea is a common gastrointestinal disorder characterized by frequent loose stools without any underlying organic cause, presents a significant health burden in India. Its prevalence is exacerbated by dietary habits, lifestyle factors, and a lack of awareness among healthcare professionals and patients alike. While existing Ayurvedic treatments focus primarily on symptom management, there is a pressing need for more rigorous clinical trials to explore effective therapeutic options tailored for faster recovery and a cost effective option The present trial can facilitate a short time bound intervention of functional diarrhea, paving the way for evidence-based Ayurvedic interventions and improved patient outcomes.
Need for the study: The increasing prevalence of functional diarrhea, particularly in India, highlights an urgent need for effective management strategies. Ayurveda, the traditional system of medicine in India, offers a unique approach to treating gastrointestinal disorders, emphasizing the balance of bodily energies (doshas) and the integration of dietary, lifestyle, and herbal interventions. There is limited empirical evidence supporting Ayurvedic treatments for functional diarrhea. Conducting systematic studies can establish a scientific basis for these practices.
Methodology: Details of triala nd control drugs: Kutaja Ghan vati is an antidiarrheal drug and is very effective in treating acute and chronic cases of diarrhea due to various etiologies. Ingredients: 1. Kutaja (Holarrhena antidysentrica) – 48g 2. Ativisha (Aconitum hetrophyllum) – 12g 3. water – 768ml B. Mugdha Rasa is also an antidiarrheal drug and helps in managing symptoms associated with diarrhoea, nausea, vomiting Ingredients: 1. Parada – 25mg 2. Khatika – 50mg
Hypothesis and Research Question: Alternate Hypothesis : Zandu Kutaja Ghana Vati and Zandu Mugdha Rasa in combination is effective in the management of Atisara (Functional Diarrheoa) Null Hypothesis : Zandu Kutaja Ghana Vati and Zandu Mugdha Rasa in combination is not effective in the management of Atisara (Functional Diarrheoa) Research Question: Whether Zandu Kutaja Ghana Vati and Zandu Mugdha Rasa in combination is effective in the management of Atisara (Functional Diarrheoa)?
Materials and Methods: Subjects who fulfill the Inclusion criteria will be included in the study Assessment Criteria : Rome IV Criteria for Functional Diarrhea Atisara lakshana Gastrointestinal Quality of Life (day 1 and day 7) Laboratory Investigations details : CBC, ESR, LFT, RFT Diagnostic Criteria: Rome IV Criteria for Functional Diarrhea Recurrent Diarrhea: Frequency: The patient experiences loose or watery stools at least 3 times per day. Duration: Symptoms should be present for at least 3 months, with onset at least 6 months before diagnosis. Patients meeting criteria for Diarrhoea predominant IBS should be excluded (That is, Greater than 25% of bowel movements with Bristol stool types 6 or 7 and less than 25% bowel movements with Bristol stool types 1 or 2) Absence of Organic Causes: Diagnostic evaluation should rule out organic causes of diarrhea, such as infections, inflammatory bowel disease, celiac disease, and malignancies. Symptoms: Characteristics: Symptoms often include urgency, frequent bowel movements, and the need to defecate immediately after meals. Consistency: The stools are typically loose or watery. Impact on Daily Life: Functional Impact: The diarrhea affects the individual’s daily functioning or quality of life Study design: Single Centre, Open Labelled, double arm, randomized controlled clinical trial. Site of study: Research OPD at Shri Dhanwantry Ayurvedic College and Hospital, Sector 46-B, Chandigarh Study duration: Period required for pre-trial preparation: 45 days (Including drug preparations) Period which may be needed for collecting the data: 3 months Period that may be required for analyzing the data: 1 month
No of groups: 2 groups
Group A- Standard control group– Zandu Kutaja Ghana Vati (30 subjects) Group B- Trial group- Zandu Kutaja Ghana Vati with Zandu Mugdha Rasa (30 subjects) •Clinical presentation of Functional Diarrheoa symptoms •Patients with Atisara lakshana •Patients with either sex, 18 to 60 years age •All patients must agree not to share medication •Patients willing to participate and sign an informed consent •Understands and agrees to comply with planned study procedures •Agrees to provide sample for testing as per protocol
•Chronic, Severe, Unstable, Uncontrolled co-existent Medical illness such as Diabetes, Hypertension, Cardiac disorders, liver, kidney disorders and lung Disorders or other
disease of concern which may put the patient at increased risk during the study
•Active cancer diagnosis, on palliative treatment or requiring current therapy with antimetabolic agents, immunotherapy or radiotherapy. •Patients on parenteral nutrition •Patients with known sensitivity or contraindication to any of the ingredients of study medication •History of bleeding haemorrhoids, haemoptysis, acid peptic diseases, ulcers and pulmonary diseases (tuberculosis, asthma, etc.) •Pregnancy and lactation •Participation in a drug interventional clinical drug trial of any nature in the three month period •Patients who are either on Allopathy medicines or on other AYUSH medications
Dosage of Medication: Group A- Standard control group will be administered Zandu Kutaja Ghana Vati 2 tablets twice daily regularly after meals along with luke warm water Group B- Trial drug Zandu Mugdha Rasa 1 tablet and Zandu Kutaja Ghana Vati 2 tablets twice daily regularly after meals along with luke warm water •Total duration of the therapy: 7 days •Follow up: Baseline, 3rd day (with medication) and 7th day (without medication for follow up)
•Randomization : R and Python programming languages will be used to generate the random number sequence . The Participants will be randomized to 2 study groups in the ratio of 1:1. Data analysis : The collected data from this randomized controlled trial (RCT) will be analyzed using both descriptive and inferential statistical methods. Descriptive statistics, including mean, standard deviation, and frequency distribution, percentage, will summarize baseline clinical characteristics and relevant variables. Inferential analyses will include, Independent sample t-test. For categorical data, Chi-square or Fisher’s Exact Test will assess associations between variables , Paired-t test can be used to assess treatment efficacy within specific groups. Depending on data distribution, non-parametric tests such as Mann-Whitney U test, Wilcoxon signed rank test will be employed . SPSS version 27 and Jamovi version 2.6.2.0,will be our primary analysis tools with isupplementary analyses in R and Python for statistical computing and for data visualization Statistical significance will be set at p < 0.05.
Research Outcome: •Trial drug Zandu Mugdha Rasa 1 tablet and Zandu Kutaja Ghana Vati 2 tablets twice daily regularly after meals along with luke warm water may be effective in managing the symptoms of Functional Diarrhea •The proposed study on Ayurvedic management of functional diarrhea could yield several significant outcomes that contribute to both clinical practice and the body of knowledge in gastroenterology and alternative medicine.
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