FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/12/099029 [Registered on: 15/12/2025] Trial Registered Prospectively
Last Modified On: 13/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Preventive 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Role of Lavangadi churna in Grahani or Irritable bowel syndrome. 
Scientific Title of Study   A randomized open labelled controlled clinical study to evaluate the efficacy of Lavangadi churna in Grahani with special reference to Irritable bowel syndrome. 
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 Manoj S Ambrad 
Designation  Pg scholar 
Affiliation  Sri Sri College of Ayurvedic science and research hospital, Bengaluru 
Address  OPD No. 5 Dept of PG Studies in Kayachikitsa Sri Sri College of Ayurvedic Science and Research Hospital 21st Km Kanakpura Rd Udayapura PO OB Chudahalli Bangalore, KARNATAKA India
OPD No. 5 Dept of PG Studies in Kayachikitsa Sri Sri College of Ayurvedic Science and Research Hospital 21st Km Kanakpura Rd Udayapura PO OB Chudahalli Bangalore, KARNATAKA India
Bangalore
KARNATAKA
560082
India 
Phone  08123524130  
Fax    
Email  manojdr005@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sowmyashree U P  
Designation  Associate professor 
Affiliation  Sri Sri College of Ayurvedic science and research hospital, Bengaluru 
Address  OPD No. 5 Dept of PG Studies in Kayachikitsa Sri Sri College of Ayurvedic Science and Research Hospital 21st Km Kanakpura Rd Udayapura PO OB Chudahalli Bangalore, KARNATAKA India
OPD No. 5 Dept of PG Studies in Kayachikitsa Sri Sri College of Ayurvedic Science and Research Hospital 21st Km Kanakpura Rd Udayapura PO OB Chudahalli Bangalore, KARNATAKA India
Bangalore
KARNATAKA
560082
India 
Phone  9743893056  
Fax    
Email  upsprasad@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sowmyashree U P  
Designation  Associate professor 
Affiliation  Sri Sri College of Ayurvedic science and research hospital, Bengaluru 
Address  OPD No. 5 Dept of PG Studies in Kayachikitsa Sri Sri College of Ayurvedic Science and Research Hospital 21st Km Kanakpura Rd Udayapura PO OB Chudahalli Bangalore, KARNATAKA India
OPD No. 5 Dept of PG Studies in Kayachikitsa Sri Sri College of Ayurvedic Science and Research Hospital 21st Km Kanakpura Rd Udayapura PO OB Chudahalli Bangalore, KARNATAKA India

KARNATAKA
560082
India 
Phone  9743893056  
Fax    
Email  upsprasad@gmail.com  
 
Source of Monetary or Material Support  
Sri Sri College of Ayurvedic Science and Research 21st KM,Kanakapura Road,Udayapura Post,Banglore. Karnataka 560082 India 
 
Primary Sponsor  
Name  Dr Manoj S Ambrad 
Address  OPD No. 5 Dept of PG Studies in Kayachikitsa Sri Sri College of Ayurvedic Science and Research Hospital 21st Km Kanakpura Rd Udayapura PO OB Chudahalli Bangalore Bangalore KARNATAKA 560082 India Bangalore KARNATAKA 560082 India 
Type of Sponsor  Other [[SELF]] 
 
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 Manoj S Ambrad  Sri Sri College of Ayurvedic Science and Research Hospital   OPD No. 5 Dept of PG Studies in Kayachikitsa Sri Sri College of Ayurvedic Science and Research Hospital 21st Km Kanakpura Rd Udayapura PO OB Chudahalli Bangalore, KARNATAKA India OPD No. 5 Dept of PG Studies in Kayachikitsa Sri Sri College of Ayurvedic Science and Research Hospital 21st Km Kanakpura Rd Udayapura PO OB Chudahalli Bangalore, KARNATAKA India
Bangalore
KARNATAKA 
08123524130

manojdr005@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRI SRI INSTITUTIONAL ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Rome IV diagnostic criteria for Irritable Bowel syndrome Recurrent abdominal pain on an average 1day per week in last three months, associated with two or more of the following criteria: 
Patients  (1) ICD-10 Condition:K929||Disease of digestive system, unspecified. Ayurveda Condition: GRAHANI-PURVARUPAM, (2) ICD-10 Condition:K319||Disease of stomach and duodenum, unspecified. Ayurveda Condition: GRAHA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Lavangadi churna , Reference: Sarangadara Samhita Madhyama khanda 6th Chapter, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Ushna Jala), Additional Information: -
(2) Medicine Name: Bruhat Gangadhara churna, Reference: Sarangadara Samhita Madyama khanda 6th chapter, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Ushna jala), Additional Information: -
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  B. INCLUSION CRITERIA
• Subjects with either gender of age group between 21-60 years.
• Subjects Diagnosed cases of Grahani.
• Established diagnosis of IBS (at least ROME-category 1V).
• Subjects who are willing to participate in the study with written consent. 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Significant Improvement in symptoms of grahani assesed based on IBS qol score after 6 weeks   Significant Improvement in symptoms of grahani assesed based on IBS qol score 6 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
Generation of the in depth analysis data on the different aspect of disease  o,30,45th 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/ Phase 3 
Date of First Enrollment (India)   27/12/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  27/12/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="4"
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  

Population based studies estimate the global prevalence of Irritable Bowel Syndrome is 10 to 20 percentage and incidence is at 1 to 2 percentage. It is one of the most common conditions encountered in the clinical practice as well as is least understood. K58.9 is a billable or specific ICD 10 CM code that can be used to indicate a diagnosis for Irritable Bowel Syndrome. In contemporary science, IBS is managed by means of patient counseling and dietary alterations, stool bulking agents, antispasmodics, anti diarrheal, anti depressants, anti flatulent therapy and gut serotonin receptors. But which may lead to the adverse effects like xerostomia, urinary hesitancy and retention, blurred vision, drowsiness, dependency on drugsSo, while considering its pathology and adverse effects of drug, its better to adopt a treatment which will manage or reverse the pathology, prevent recurrence, and to ensure non occurrence of the above mentioned adverse effects. As in the Grahani Agnimandhya is important factor in the samprapti, so it should be treated with Agnivardhana yogas. Therefore Lavangadi churna is selected as trial drug. Bruhat Gangadhara churna, which is a proven drug, in Grahani roga with special reference to Irritable bowel syndrome is taken as control drug. Hence here an attempt has been made to evaluate the comparative clinical study of Lavangadi Churna and Bruhat Gangadhara Churna in the management of Grahani. Lavangadi Churna has 19 drugs. Most of the drugs are having Katu and Kashaya rasa, Laghu  and Ruksha guna, Ushna veerya, katu vipaka, Ama pachaka and Agni Deepana properties, which might help in the Samprapti vighatana of Grahani roga. Hence the current study is undertaken.


 
Close