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CTRI Number  CTRI/2024/11/076915 [Registered on: 18/11/2024] Trial Registered Prospectively
Last Modified On: 12/09/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A case study on Karavellaka Swarasa Bhavita Haritaki Churna as Nitya Vrechana Drug in Obese Type II Diabetics 
Scientific Title of Study   To study the efficacy of Karavellaka Swarasa Bhavita Haritaki Churna as Nitya Virechana in Sthula Pramehi (Obese Type II Diabetics) - A single arm open labelled pilot 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  Chavhan Amruta Pandurang 
Designation  4th year BAMS student 
Affiliation  Sushrutha Ayurvedic Medical College and Hospital 
Address  OPD no.2 ground floor Sushrutha Ayurvedic Medical College and Hospital Prashanti Kutiram Jodi Bingipura Jigani Bengaluru

Bangalore
KARNATAKA
560105
India 
Phone  9766393182  
Fax    
Email  amrutachavhan2000@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Chavhan Amruta Pandurang 
Designation  4th year BAMS student 
Affiliation  Sushrutha Ayurvedic Medical College and Hospital 
Address  OPD no.2 ground floor Sushrutha Ayurvedic Medical College and Hospital Prashanti Kutiram Jodi Bingipura Jigani Bengaluru


KARNATAKA
560105
India 
Phone  9766393182  
Fax    
Email  amrutachavhan2000@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ramya R V 
Designation  Assistant Professor 
Affiliation  Sushrutha Ayurvedic Medical College and Hospital 
Address  OPD no.2 ground floor Sushrutha Ayurvedic Medical College and Hospital Prashanti Kutiram Jodi Bingipura Jigani Bengaluru

Bangalore
KARNATAKA
560105
India 
Phone  9589165485  
Fax    
Email  ramyarv1985@gmail.com  
 
Source of Monetary or Material Support  
Sushrutha Ayurvedic Medical College and Hospital Prashanti Kutiram Jodi Bingipura Jigani Bengaluru Karnataka India Pincode - 560105 
 
Primary Sponsor  
Name  Sushrutha Ayurvedic Medical College and Hospital 
Address  Sushrutha Ayurvedic Medical College and Hospital Prashanti Kutiram Jodi Bingipura Jigani Bengaluru Karnataka India Pincode - 560105 
Type of Sponsor  Private medical college 
 
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 Ramya R V  Sushrutha Ayurvedic Medical College and Hospital  Department of Panchakarma OPD no. 2 ground floor Sushrutha Ayurvedic Medical College and Hospital Prashanti Kutiram Jodi Bingipura Jigani Bengaluru
Bangalore
KARNATAKA 		 9589165485

ramyarv1985@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SAMCH & H-IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: PRAMEHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Karavellaka Swarasa Bhavita Haritaki Churna, Reference: Charaka Kalpa Sthana (12/47), Route: Oral, Dosage Form: Churna/ Powder, Dose: 12(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: Ushna Jala), Additional Information: -
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Clinical symptoms of Sthula Pramehi
2. BMI more than 25
3. Pre diabetics levels with increased lipid levels and BMI more than 25 
 
ExclusionCriteria 
Details  • Volunteers suffering from major Systemic diseases
• Chronic diseases with long run of medications
• Insulin dependent DM-II, HbA1C above 9
• Hypertensive above 150/100 mmHg
• Pregnant ladies & lactating women
• Participants currently taking medications or supplements that may affect the present study
• Participants currently enrolled in any other clinical trials or having participated in any other clinical trial in the past 30 days.
• Participants with history or currently under substance abuse.
• Any other conditions which investigator things may jeopardize the study.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the efficacy of the formulation Karvellaka Swarasa Bhavita Haritaki Churna as Nitya Virechana in Sthula Pramehi (Obese Type II Diabetics) – A single arm open labelled pilot study  on 0 day and on 16th day 
 
Secondary Outcome  
Outcome  TimePoints 
1. To assess the role of Nitya Virechana in Sthula Pramehi (Obese Type II Diabetics).
2. To prove the efficacy of Karvellaka Swarasa Bhavita Haritaki Churna as Nitya Virechana drug in Pre Diabetics with raised lipids & BMI.
 		 0 day & 16th day 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
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)   15/01/2025 
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)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Ayurveda describes a set of complex clinical conditions with frequent, abnormal micturition, collectively called Prameha which has similar symptoms in Diabetes Mellitus1. For the persons who indulge constantly in Avyayama, Divaswapna, Kaphavardhaka Ahara Vihara etc2, the Tridosha get vitiated, mix with Medas, get localised in Vasti and manifests has Prameha which can be considered as Kapha Pradhana Tridosha Vyadhi.3

 

Diabetes Mellitus is marked by hyperglycemia due to absolute insulin deficiency or diminished biological effectiveness. Epidemiological data from a 2019-2021 National Family Health Survey study reveals alarming prevalence rates: 8.65% for males and 7.39% for females, with abdominal obesity affecting 51.77% of males and 57.91% of females.4 Furthermore, the study indicates an 8.4% pre-diabetes prevalence and 6.8% diabetes prevalence, with obesity increasing diabetes risk by 8.3-fold compared to normal weight individuals.5

 

The selected poly-drug combination aims to manage Sthaulya and Prameha Roga, which share common causes and complications. Both being Santarpanjanya Vyadhis,6 requiring similar treatment. For Sthoola Pramehi, Apatarpana Chikitsa i.e. Shodhana, Udvarthana7 is the treatment protocol mentioned in classics. However, time constraints may make Shodhana (Vamana, Virechana) challenging, in such cases Nitya Virechana offers an alternative.

 

Haritaki (Terminalia chebula Retz) Churna, a well-established Nitya Virechana drug, has demonstrated anti-hyperglycemic properties due to its rich content of tannins and flavonoids, which reduce glucose absorption.8,9,10 Similarly, Karavellaka (Momordica Charantia L.) contains Charantin, a cucurbitane-type triterpenoid with proven antidiabetic effects, particularly in protecting pancreatic beta cells from toxicity.11,12,13 Notably, both drugs possess Teekshna, Ushna, and Rooksha Guna, enabling them to target Medas and align with the principles of Apatarpana Chikitsa.

 

According to Charaka Kalpa Sthana (12/47), Dravya Guna Vruddhi enhances drug efficacy by giving Bhavana with the Swarasa or Kashaya of same Dravya or the Dravya which has similar properties. This reduces the required dosage, shortens treatment duration, and minimizes complications.

 
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