| CTRI Number |
CTRI/2025/07/090823 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
25/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Two Ayurvedic Herbal Remedies for Managing Irritable Bowel Syndrome (IBS) |
|
Scientific Title of Study
|
Effectiveness of Dhanyavilwadhi Kashaya and Nagarapippalyadhi Kashaya in the Management of Irritable Bowel syndrome - A Comparative Clinical Study |
| 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 Suresh V S |
| Designation |
PhD Scholar |
| Affiliation |
Glocal College of Ayurvedic Medical Science and Research Centre |
| Address |
Department of Kayachikitsa
Glocal college of Ayurvedic Medical Science and Research Centre, Delhi Yamunotri Marg State Highway 57, Mirzapur pole, Dist Saharanpur, Uttar Pradesh, India 247121
Saharanpur
UTTAR PRADESH
247121
India |
| Phone |
9605987698 |
| Fax |
|
| Email |
dr.suresh.vs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Remani K K |
| Designation |
Professor and PhD Guide |
| Affiliation |
Glocal College of Ayurvedic Medical Science and Research Centre |
| Address |
PhD Guide and Professor
Research Department of Kayachikitsa
Glocal college of Ayurvedic Medical Science and Research Centre, Delhi Yamunotri Marg State Highway 57, Mirzapur pole, Dist Saharanpur, Uttar Pradesh, India 247121
Saharanpur
UTTAR PRADESH
247121
India |
| Phone |
9446389582 |
| Fax |
|
| Email |
dr.kkremani.ayur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suresh V S |
| Designation |
PhD Scholar |
| Affiliation |
Glocal College of Ayurvedic Medical Science and Research Centre |
| Address |
Department of Kayachikitsa
Glocal college of Ayurvedic Medical Science and Research Centre, Delhi Yamunotri Marg State Highway 57, Mirzapur pole, Dist Saharanpur, Uttar Pradesh, India 247121
Saharanpur
UTTAR PRADESH
247121
India |
| Phone |
9605987698 |
| Fax |
|
| Email |
dr.suresh.vs@gmail.com |
|
|
Source of Monetary or Material Support
|
| ITM Ayurvedic Medical College and Hospital, Chehari, Phahendra Road, Maharajganj, UP 273303 |
|
|
Primary Sponsor
|
| Name |
Dr Suresh V S |
| Address |
PhD Scholar, Department of Kayachikitsa, Glocal College of Ayurvedic Medical Science and Research Centre, Delhi Yamunotrimarg State Highway 57, Mirzapore pole, District Shaharanpur, Uttarpradesh, India 247121 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof Dr H Abdul Kareem |
ITM Ayurvedic Medical college Hospital |
Department OP Kayachikitsa
Room No 1
Chehari
Pharenda Road
Maharajgang
UP 273303
Maharajganj
UTTAR PRADESH |
9880449252
drkareem81@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE GLOCAL UNIVERSITY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K582||Mixed irritable bowel syndrome. Ayurveda Condition: GRAHANIDOSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dhanyavilwadi kashayam, Reference: Sahasrayogam. (2007). Sujnapriya commentary (27th ed., p. 49). Vidyarambham Publishers. Grahanichikitsakruma chapter, Sloka 6, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 96(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Nagarapippalyadi Kashayam, Reference: Sahasrayogam. (2007). Sujnapriya commentary (27th ed., p. 49). Vidyarambham Publishers. Grahanichikitsakruma chapter, Sloka 8., Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 96(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Jeeraka and Saindhava), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Subjects who have signed the informed consent
2 Patients having symptoms of IBS diagnosed based on Rome criteria |
|
| ExclusionCriteria |
| Details |
Patients having an age that is less than 18 and greater than 60 years
Patients suffering from Acute diarrhoea
Intestinal TB
Ulcerative colitis
Gastric and Peptic ulcers
Diabetes and Chronic kidney disorder
Hyperthyroidism
Malignancies
Amoebic dysentery |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| ROME Criteria-based improvement |
0th day
15th day
30th day
45th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
ROME Criteria-based improvement
Change in individual symptom severity |
0th day
15th day
30th day
45th day
60th day |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
25/07/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
|
Brief Summary
|
The prevalence of IBS ranges from 10% to 15% worldwide, making it a major health concern. The condition leads to chronic symptoms which significantly impact patients’ quality of life and daily functioning. Women are two to four times more likely to develop IBS than men. Age-related onset of IBS symptoms occurred predominantly in patients younger than 45 years, but prevalence rose again in the elderly. The development of symptoms in people older than 40 years does not exclude IBS but should prompt a closer search for an underlying organic etiology. The prevalence varies according to country and criteria used to define IBS. Allopathic treatments have limited success in curing Grahani disease, and patients often experience significant complications. Effective management strategies are essential to alleviate these symptoms and enhance patient well-being. So, this study will compare the effectiveness of Dhanyavilwadi Kashaya and Nagarapippalyadi Kashaya in managing irritable bowel syndrome (IBS) symptoms.
This research is vital for improving treatments for irritable bowel syndrome (IBS), which significantly impacts daily life. Conventional therapies often provide inadequate relief and can have side effects, creating a need for effective alternatives. Dhanyavilwadi Kashaya and Nagarapippalyadi Kashaya are Ayurvedic formulations that promote digestive health and dosha balance. However, scientific evidence supporting their efficacy is limited. This study aims to provide empirical data on their effectiveness.
Null Hypothesis:
There is no significant difference in the efficacy of Dhanyavilwadi Kashaya and Nagarapippalyadi Kashaya in the management of irritable bowel syndrome.
Alternative Hypothesis
There is a significant difference in the effectiveness of Dhanyavilwadi Kashaya significantly more effective than Nagarapippalyadi Kashaya in the management of irritable bowel syndrome
|