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CTRI Number  CTRI/2023/07/054652 [Registered on: 03/07/2023] Trial Registered Prospectively
Last Modified On: 28/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Diagnostic
Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Clinical Trial to Study the Effect of Salsaradi Gana Bhavit Haritaki in Patients with High Glucose Levels in Blood. 
Scientific Title of Study   A clinical study of Salsaradi Gana Bhavit Haritaki in the management of Sthoola Pramehi (Diabetes Mellitus – Type – II).  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Bhagyashreeben Valvi 
Designation  PG Scholar 
Affiliation  Government Akhandanand Ayurveda College, Ahmedabad  
Address  Opd No 4, Kayachikitsa Department Government Akhandanand Ayurveda College Bhadra, Ahmadabad, Gujarat

Ahmadabad
GUJARAT
380001
India 
Phone  6356257310  
Fax    
Email  valvibhagyashri110@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Surendra A Soni 
Designation  Head of Department 
Affiliation  Government Akhandanand Ayurveda College, Ahmedabad  
Address  Opd No 4, Kayachikitsa Department Government Akhandanand Ayurveda College Bhadra, Ahmadabad, Gujarat Ahmadabad GUJARAT 380001 India

Ahmadabad
GUJARAT
380001
India 
Phone  9408441150  
Fax    
Email  surendraasoni@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Surendra A Soni 
Designation  Head of Department 
Affiliation  Government Akhandanand Ayurveda College, Ahmedabad  
Address  Opd No 4, Kayachikitsa Department Government Akhandanand Ayurveda College Bhadra, Ahmadabad, Gujarat

Ahmadabad
GUJARAT
380001
India 
Phone  9408441150  
Fax    
Email  surendraasoni@gmail.com  
 
Source of Monetary or Material Support  
Government Akhandanand Ayurveda College, Ahmedabad Opd No 4, Kayachikitsa Department Government Akhandanand Ayurveda College Bhadra, Ahmadabad, Gujarat  
 
Primary Sponsor  
Name  Government Akhandanand Ayurveda College, Ahmedabad 
Address  Opd No 4, Kayachikitsa Department Government Akhandanand Ayurveda College Bhadra, Ahmadabad, Gujarat  
Type of Sponsor  Government 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 
Bhagyashreeben Valvi  Government Akhandanand Ayurveda College, Ahmedabad   Opd No 4, Kayachikitsa Department Government Akhandanand Ayurveda College Bhadra, Ahmadabad, Gujarat
Ahmadabad
GUJARAT 
6356257310

valvibhagyashri110@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE  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
1Comparator ArmDrugOther than Classical(1) Medicine Name: vijaysaradi kwatha, Reference: NA, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 40 Days, anupAna/sahapAna: No, Additional Information: -
2Intervention ArmDrugOther than Classical(1) Medicine Name: Salsaradi gana bhvavit haritaki , Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 40 Days, anupAna/sahapAna: Yes(details: -warm water), Additional Information:
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients of either sex in the age group of above 18 years and below 65 years.
2. Classical signs and symptoms of Prameha.
3. Fasting plasma glucose ≤ 200 mg/dl, Post Prandial glucose level ≤ 300 mg/dl.
4. Both insulin-dependent and non-insulin-dependent Type – II Diabetes Mellitus patients will be included.
5. Both newly diagnosed patients on allopathic treatment will be included in this study.
6. The dose of Modern Medicine will be adjusted and tapered during the period of trial as per need.
7. Patients having BMI (Body Mass Index) ≥ 25 and ≤ 35 will be taken for the study.
 
 
ExclusionCriteria 
Details  1. Patients of either sex in the age group of above 18 years and below 65 years.
2. Classical signs and symptoms of Prameha.
3. Fasting plasma glucose ≤ 200 mg/dl, Post Prandial glucose level ≤ 300 mg/dl.
4. Both insulin-dependent and non-insulin-dependent Type – II Diabetes Mellitus patients will be included.
5. Both newly diagnosed patients on allopathic treatment will be included in this study.
6. The dose of Modern Medicine will be adjusted and tapered during the period of trial as per need.
7. Patients having BMI (Body Mass Index) ≥ 25 and ≤ 35 will be taken for the study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in laboratorial parameters as well as signs and symptoms of Sthoola Pramehi (Type – II Diabetes Mellitus).  40 Days 
 
Secondary Outcome  
Outcome  TimePoints 
To improve quality of life by reducing high blood glucose level.  40 days 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   15/07/2023 
Date of Study Completion (India) 28/08/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
No 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

India has an estimated 77 million people with Diabetes, which makes it the second most affected in the world, after China. One in six people (17%) in the world with diabetes is from India. Diabetes is one of the most challenging diseases for medical science to cure like other systemic diseases, as it has more serious complications due to negligence in management.

Modern medical science treats the condition with Oral hypoglycemic agents and Insulin to manage high blood sugar levels. The patient must take medicines to control blood sugar levels for a lifelong period. Though high blood sugar levels are managed by oral hypoglycemic agents and insulin, long-term use can cause many side effects like GI discomfort, heartburn, polyuria, etc. Hence, there is a scope for Ayurveda treatment for the management of high blood sugar levels.

The drugs in the trial formulation have been described by Acharya Sushruta collectively as Salasaradi Gana having action by their Kapha – Medoshoshan properties .

Haritaki is mainly of Kasaya Rasa, Ushna, Ruksa Guna. It acts as Kaphgna, these qualities of Haritaki acts as a cleanser and it also improves digestion. Same as in Diabetes (Prameha) there is Dusti of Medovaha Srotas and Dhatvagni, especially Mandya. Hence there is a need for Dravya which is of Usṇa, Rukṣa Gunas with Lekhan & Shoshan properties to cleanse the Medovaha Stratos and to increase the Dhatvagni.

So, as per this concept, it is decided to use Haritaki processed in Salsaradi Gana Dravya Kwath 7 times to sharpen the action of Haritaki with Rasayan property. That’s why this research plan has been designed as per Rasayan Vidhi with Aarohi-Avarohi Krama of the drug during the trial period.

Vijaysaradi Kwath contains mainly Tikta Kashaya Rasa and has Rukshana properties Tikta Rasa has Kledameda- vasa-majja-lasika Shoshana properties 5 and is known to be successfully used for the treatment of Madhumeha.

 




 
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