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CTRI Number  CTRI/2025/08/093174 [Registered on: 18/08/2025] Trial Registered Prospectively
Last Modified On: 14/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical study to evaluate the efficacy of Herbal extract formulation in managing Obesity 
Scientific Title of Study   A pilot study to evaluate the safety and efficacy of Murraya koenigii (Herbal Extract Formulation) in the management of Obesity 
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 Sanjay M Jachak 
Designation  Professor and Former Head 
Affiliation  NIPER, Mohali 
Address  Department of Natural Products NIPER SAS Nagar

Chandigarh
CHANDIGARH
160047
India 
Phone  9888235595  
Fax    
Email  sanjayjachak@niper.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Sanjay M Jachak 
Designation  Professor and Former Head 
Affiliation  NIPER, Mohali 
Address  Department of Natural Products NIPER SAS Nagar

Chandigarh
CHANDIGARH
160047
India 
Phone  9888235595  
Fax    
Email  sanjayjachak@niper.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Sanjay M Jachak 
Designation  Professor and Former Head 
Affiliation  NIPER, Mohali 
Address  Department of Natural Products NIPER SAS Nagar

Chandigarh
CHANDIGARH
160047
India 
Phone  9888235595  
Fax    
Email  sanjayjachak@niper.ac.in  
 
Source of Monetary or Material Support  
Shri Dhanwantry Ayurvedic College and Hospital, Sector 46-B, Chandigarh, Pin:160047, UT, India 
 
Primary Sponsor  
Name  SDACH Research Fund 
Address  Shri Dhanwantry Ayurvedic College and Hospital, Sector 46-B, Chandigarh, Pin 160047, India 
Type of Sponsor  Research institution and hospital 
 
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 Rijin Mohan  Research OPD Room no 102  Shri Dhanwantry Ayurvedic College and hospital, Sector 46-B, Chandigarh, Pin:160047, India
Chandigarh
CHANDIGARH 		 9496463399

drsaranyarijin@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IECSDACH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E669||Obesity, unspecified. Ayurveda Condition: MEDOROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Murraya koenigii AEF , Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 2(NA), Frequency: od, Bhaishajya Kal: Antarabhakta, Duration: 12 Weeks, anupAna/sahapAna: No, Additional Information: -
2Comparator ArmDrugOther than Classical(1) Medicine Name: Garcinia cambogia, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 2(NA), Frequency: od, Bhaishajya Kal: Antarabhakta, Duration: 12 Weeks, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Subjects of any gender in the age group of 18-60 years
2.Subjects willing to provide written informed consent.
3.Subjects with BMI greater than or equal to 30 and Waist-Hip Ratio greater than 0.85 in female and greater than 0.90 in male
 
 
ExclusionCriteria 
Details  1. Patients on any medications including Statins that are known to influence weight and/or lipids within the last 3 months.
2. Patient using the medications as systemic corticosteroids (nasal and inhaled corticosteroids are permitted), drugs such as thiazides, Anti-depressants, anti-anxiety, mood stabilizers beta-blockers, retinoids, highly active antiretroviral agents, cyclosporine, tacrolimus, estrogen and progestins, and glucocorticoids, bile acid resins, prescription omega-3 fatty acids, cyclical or non- continuous hormone therapy (estrogen or testosterone) excepted stable oestroprogestative or progestative contraception i.e. started at least three months preceding the screening visit, Patient taking antioxidant agents within 6 weeks prior to screening.
3. Patients with history of hepatic dysfunction (elevation in AST or ALT of greater than 2 times the laboratory reference)
4. Renal dysfunction
5. Known cases of uncontrolled Diabetes mellitus Glycosylated hemoglobin 8 percentage or greater.
6. Uncontrolled hypertension sitting BP greater than or equal to160 systolic or greater than or equal to 100 mmHg diastolic
7. Female participants who are pregnant, intend to become pregnant, are breastfeeding, or not willing to use effective contraceptive precautions during the study.
8. Known cases of Smoking, drug abuse and alcoholism
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pharmacy-controlled Randomization 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Assessment of safety is through the changes in CBC, LFT and RFT before and after treatment with intervention  Day 1 and Day 90 
 
Secondary Outcome  
Outcome  TimePoints 
• Change in parameters of Lipid profile (LDL, Total Cholesterol, HDL, Triglycerides, VLDL), HbA1c [Time Frame: Baseline, 90th day]
• Changes in the atherogenic indices viz. Atherogenic index of plasma (AIP), Castelli Risk Index I and II (CRI), atherogenic coefficient (AC), and non-high density lipoprotein cholesterol (non- HDLc) (NHC), [Time Frame: Baseline, 90th day].
• Change in IWQOL-Lite-CT
 		 [Time Frame: Baseline, 90th day] 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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 3/ Phase 4 
Date of First Enrollment (India)   15/09/2025 
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="0"
Months="6"
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  

Brief Summary of Obesity NIPER Protocol

Version 002 PROPOSAL FOR COLLABORATIVE CLINICAL RESEARCH PROJECT A pilot study to evaluate the safety and efficacy of Murraya koenigii Herbal Extract Formulation in the management of Obesity Submitted by Shri Dhanwantry Ayurvedic College and Hospital, Sector 46 B, Chandigarh National Institute of Pharmaceutical Education and Research, S.A.S. Nagar, Mohali Title of the Study A pilot study to evaluate the safety and efficacy of Murraya koenigii Herbal Extract Formulation in the management of Obesity Aims and objectives Primary objective To evaluate and compare the efficacy of herbal extract formulations Murraya koenigii and Garcinia cambogia in the management of Obesity. Secondary Objective To evaluate the safety of herbal extract formulations Murraya koenigii and Garcinia cambogia in the management of Obesity To evaluate the efficacy of herbal extract formulations Murraya koenigii and Garcinia cambogia in the management of Obesity Study Design Sample size justification Calculated for piolet study minimal number. Study Intervention Trial DrugIntervention references The preclinical data of the trial drugintervention are as follows Summary of obtained results from in vitro cell viability and antiobesity activity in 3T3L1 cells and in vivo anti obesity activity on C57BL6J mice and repeated dose toxicity study and pharmacokinetic study on Sprague Dawley rats A study described earlier from our lab revealed that dichloromethane, ethyl acetate, and methanol extracts of M. koenigii leaves exhibited more than 80 pancreatic lipase inhibitory activity. The carbazole alkaloids, mahanimbine and koenigicine at concentrations of 15 M, while girinimbine and koenimbine at concentrations of 4 M, did not show any toxicity to 3T3L1 adipocytes. According to in vitro antiobesogenic assay, koenigicine showed lowest lipid accumulation 41.495.53 at 15 M concentration compared to control cells 100 lipid accumulation and positive control, quercetin 50.976.39 at 25 M concentration. Koenimbine and girinimbine at 15 M concentration revealed 45.292.58 and 47.950.13 while mahanimbine showed 50.764.09 lipid accumulation in 3T3L1 adipocytes. Thus, the preclinical studies using 3T3L1 cell lines have provided substantial evidence supporting the efficacy of M. koenigii. Biomarkers identified with good antiadipogenic potential should be further studied in vivo mice models of obesity to gain insights into the futuristic utilization of curry leaves as a nutraceutical intervention for prevention of obesity. Figure 1 Annexure I shows the cell viability assay performed on 3T3L1 adipocytes, and the in vitro antiadipogenic assay of carbazole alkaloids of Murraya koenigii is shown in Figure 2 Annexure I. Both Murraya koenigii methanolic extract MKME and alkaloidenriched fraction AEF displayed antiobesogenic activity at 25 gmL concentration in vitro and showed 54.06 3.86 and 37.46 3.17 lipid accumulation, respectively compared to control. Further, supplementation of AEF and MKME in high fat diet HFDfed C57BL6J mice helped in controlling weight gain, improved dyslipidemia and glucose intolerance significantly. AEF showed better antiobesity activity than MKME both in vitro and in vivo study. AEF not only lowered LDL levels, but simultaneously elevated HDL levels, which is the pivotal insight of the study. Repeated administration of AEF up to 1 gkg dose for 28 days showed no pathological tissue damage. Both MKME and AEF


 
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