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 |
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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 |
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 |
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: PRAMEHAH, |
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Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Comparator Arm | Drug | Other 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: - | 2 | Intervention Arm | Drug | Other 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: |
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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.
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|
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.
|
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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
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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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