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CTRI Number  CTRI/2026/03/105129 [Registered on: 02/03/2026] Trial Registered Prospectively
Last Modified On: 02/03/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   An Open Label Clinical Trial to Assess the Effectiveness of Nabhi Oil Application in Adults with Agnimandya 
Scientific Title of Study   A Single-arm, Open Label Clinical Trial to Assess the Effectiveness of Nabhi Oil Application Over 30 Days in Adults with Agnimandya 
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 CHHAYA TANMANE 
Designation  HOD and Professor  
Affiliation  Bhausaheb mulak ayurvedic mahavidylaya nandanwan nagpur 
Address  OPD NO 8 GROUND FLOR DEPARTMENT OF KAYACHIKITSA BHAUSAHEB MULAK AYURVED MAHAVIDYALAYA AND HOPSITAL Great Nag Road KDK College Nandanvan Nagpur
OPD NO 8 GROUND FLOOR DEPARTMENT OF KAYACHIKITSA BHAUSAHEB MULAK AYURVED MAHAVIDYALAYA AND HOPSITAL Great Nag Road KDK College Nandanvan Nagpur
Nagpur
MAHARASHTRA
440009
India 
Phone  09422174598  
Fax    
Email  ctanmane@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR CHHAYA TANMANE 
Designation  HOD and Professor  
Affiliation  Bhausaheb mulak ayurvedic mahavidylaya nandanwan nagpur 
Address  OPD NO 8 GROUND FLOOR DEPARTMENT OF KAYACHIKITSA BHAUSAHEB MULAK AYURVED MAHAVIDYALAYA AND HOPSITAL Great Nag Road KDK College Nandanvan Nagpur
OPD NO 8 GROUND FLOOR DEPARTMENT OF KAYACHIKITSA BHAUSAHEB MULAK AYURVED MAHAVIDYALAYA AND HOPSITAL Great Nag Road KDK College Nandanvan Nagpur
Nagpur
MAHARASHTRA
440009
India 
Phone  09422174598  
Fax    
Email  ctanmane@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Mayuri Shingnapurkar 
Designation  Assistant Professor 
Affiliation  Bhausaheb mulak ayurvedic mahavidylaya nandanwan nagpur 
Address  OPD NO 8 GROUND FLOOR DEPARTMENT OF KAYACHIKITSA BHAUSAHEB MULAK AYURVED MAHAVIDYALAYA AND HOPSITAL Great Nag Road KDK College Nandanvan Nagpur
OPD NO 8 GROUND FLOOR DEPARTMENT OF KAYACHIKITSA BHAUSAHEB MULAK AYURVED MAHAVIDYALAYA AND HOPSITAL Great Nag Road KDK College Nandanvan Nagpur
Nagpur
MAHARASHTRA
440009
India 
Phone  8600995023  
Fax    
Email  mayurirekha1410@gmail.com  
 
Source of Monetary or Material Support  
Ved Sanjeevani Pvt Ltd monetary support Bhausaheb Mulak Ayurved Mahavidyalaya and hosptial for trial recruitment 
 
Primary Sponsor  
Name  Ved Sanjeevani Pvt Ltd 
Address  153 Samaj Bhushan Society Wadi Nagpur 440023 
Type of Sponsor  Other [Pvt Manufacturing Company] 
 
Details of Secondary Sponsor  
Name  Address 
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 CHHAYA TANMANE  BHAUSAHEB MULAK AYURVED MAHAVIDYALAYA HOSPITAL AND RESEARCH CENTRE   OPD NO 8 GROUND FLOOR DEPARTMENT OF KAYACHIKITSA BHAUSAHEB MULAK AYURVED MAHAVIDYALAYA AND HOPSITAL NANDAVAN GREAT NAG ROAD KDK COLLEGE CAMPUS NANDANVAN NAGPUR
Nagpur
MAHARASHTRA 		 9422174598

ctanmane@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BMAM  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K928||Other specified diseases of the digestive system. Ayurveda Condition: AGNIVAISHAMYAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Nabhi Oil, Reference: NA, Route: Topical, Dosage Form: Taila, Dose: 10(drops), Frequency: hs, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
(2) Medicine Name: 30 Days, Reference: NA, Route: -, Dosage Form: Taila, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Adults aged 18 to 60 years
2 Patients who have presence of digestive complaints like Udgar Ashuddh Kshudhamandya Abdominal bloating Flatulence Heaviness after meals Bowel dissatisfaction
3 Patients who are willing to provide written informed consent
4 Patients who are able to comply with study visits and assessments
5 Adults 18–60 years who during a 7-day run-in demonstrate the following based on weekly means
Abdominal bloating more than 2
Flatulence score more than 2
Heaviness after meals more than 2
Bowel satisfaction less than 2
 
 
ExclusionCriteria 
Details  Patients who are diagnosed gastrointestinal pathology FOR EG IBD celiac disease
Patients who have severe systemic illness or immunosuppression
Patients who are currently using anti-inflammatory antioxidant or immunomodulatory Drugs
Hemoglobin levels less than 9
Females who are pregnant or lactating mothers
Patients who have known allergy to any component of the trial oils
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Subjective criteria
Udgar Shuddhi
Kshudha
Agnibala
Abdominal bloating
Flatulence
Heaviness after meals
Bowel satisfaction
objective criteria
Abdominal circumference Umbilicus below and above
Weight
CBC
 		 0th day
10th day
20th day
30th day
40th day
30 days with intervention
40th day without intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Objective criteria
Abdominal circumference Umbilicus below and above
Weight
CBC
 		 0th day
10th day
20th day
30th day
40th day
30 days with intervention
40th day without intervention 
 
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" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   02/04/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  02/04/2026 
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 Yet Recruiting 
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  

This is a single arm open label clinical trial designed to evaluate the effectiveness and safety of Nabhi Taila Digestion and Detox Nabhi Oil in adults diagnosed with Agnimandya
The intervention consists of once daily topical application of Nabhi Oil over the umbilical region for a duration of thirty days with periodic assessments and post intervention follow up

The primary outcome measures include changes in Udgar shuddhi quality of belching and Kshudha appetite which are established Ayurvedic clinical parameters reflecting digestive function and Jatharagni status
Secondary outcome measures include assessment of Agnibala associated gastrointestinal symptoms such as abdominal bloating flatulence heaviness after meals and bowel satisfaction anthropometric parameters and selected laboratory investigations

The study aims to generate clinical evidence for the therapeutic utility of Nabhi Taila as a non invasive adjunctive Ayurvedic intervention for the management of Agnimandya

Hypothesis

Null Hypothesis
There is no significant improvement in digestive symptoms Udgar shuddhi and Kshudha following Nabhi Oil application in adults with Agnimandya

Alternate Hypothesis
Nabhi Oil application results in a significant improvement in digestive symptoms Udgar shuddhi and Kshudha in adults with Agnimandya

 
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