| 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
|
|
|
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
|
|
|
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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 |
|
|
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 drugs. So, 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. |