| CTRI Number |
CTRI/2026/01/100003 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
25/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To Study The Effect Of Lavangadya Churna And Dhatri Nisha Churna In The Treatment Of Type 2 Diabetes Mellitus |
|
Scientific Title of Study
|
A Open Randomised Controlled Clinical Trial Of Lavangadya Churna With Dhatri Nisha Churna In Management Of Madhumeh With Special Reference To 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 |
Dr Amarjeet Appaso Kolekar |
| Designation |
PG Scholar |
| Affiliation |
Lrp Ayurvedic Medical College And Hospital PG institute and Research Centre Urun Islampur Sangali |
| Address |
OPD 1 Kayachikitsa Department Lrp Ayurvedic Medical College And Hospital PG institute and Research Centre Sangli 415409 Maharashtra India
Sangli
MAHARASHTRA
415409
India |
| Phone |
7218948330 |
| Fax |
|
| Email |
amarjeetkolekar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhinandan Patil |
| Designation |
Professor |
| Affiliation |
Lrp Ayurvedic Medical College And Hospital PG institute and Research Centre Sangli |
| Address |
OPD 1 Kayachikitsa Department Lrp Ayurvedic Medical College And Hospital PG institute and Research Centre Sangli 415409 Maharashtra India
Sangli
MAHARASHTRA
415409
India |
| Phone |
9890205000 |
| Fax |
|
| Email |
drabhinandanpatil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhinandan Patil |
| Designation |
Professor |
| Affiliation |
Lrp Ayurvedic Medical College And Hospital PG institute and Research Centre Sangli |
| Address |
OPD 1 Kayachikitsa Department Lrp Ayurvedic Medical College And Hospital PG institute and Research Centre Sangli 415409 Maharashtra India
Sangli
MAHARASHTRA
415409
India |
| Phone |
9890205000 |
| Fax |
|
| Email |
drabhinandanpatil@gmail.com |
|
|
Source of Monetary or Material Support
|
| Loknete Rajarambapu Ayurvedic Medical College Hospital PG institute and Research Centre Urun Islampur Sangli |
|
|
Primary Sponsor
|
| Name |
Dr Amarjeet Appaso Kolekar |
| Address |
Lrp Ayurvedic Medical College And Hospital PG Institute And Research Centre Urun Islampur Sangli 415409 Maharashtra India |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Dr Amarjeet Appaso Kolekar |
Lrp Ayurvedic Medical College Hospital PG institute and Research Centre Urun Islampur Sangli |
OPD 1 Kayachikitsa Department Lrp Ayurvedic Medical College Hospital PG institute and Research Centre Urun Islampur Sangli
Sangli
MAHARASHTRA |
7218948330
amarjeetkolekar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Lrp Ayurvedic Medical College Hospital PG Institute And Research Centre Urun Islampur Sangli Instutional Ethical Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Lavangadya Churna , Reference: Bharat Bhaishjya Ratnakar Chaturth Bhag 6227, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Dhatri Nisha Churna , Reference: Ashtang Hruday Uttarsthan 40 , Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -), Additional Information: - |
|
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Diagnosed patient with type II Diabetes Mellitus with hyperglycaemia on treatment one or two types of Oral Hypoglycemic Agent
2 Age 30 To 60 years irrespective of sex and socioeconomic status will be selected for study
3 Blood sugar level Fasting is more than 126 Miligram Per Decilitre and less than 200 Miligram Per Decilitre and post prandial blood sugar level more than 200 Miligram Per Decilitre And less than 300 Miligram Per decilitre with symptoms of Prameha like Prabhuta Mootrata Nocturia Trishna Kshudhadhikya Swedaadhikya Kara Pada Tala Daha Nidraadhikya 4 HbA1c 6.5 Percentage to 8 Percentage |
|
| ExclusionCriteria |
| Details |
1 Newly diagnosed Diabetes Mellitus with or without on treatment OHA or Insulin
2 Diagnosed Diabetes Mellitus with on treatment more than two OHA
3 Fasting bsl is more than 200mg per dl and PP bsl is more than 300mg per dl
4 Known Case Of Insulin Dependent Diabetes Mellitus URINARY Tract Infection Ketoacidosis acute infection anywhere on body Gangrene retinopathy nephropathy Diabetic foot Gestational diabetes |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Study The Effect OF Lavangadya Churna In Management Of Madhumeha With Special Reference To Diabetes Mellitus Type II |
Initial Assessment 0th Day
Follow up on 30th 60th Day
Final Assessment 90th Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the results of trial group with standard group
To study Madhumeha and Prameha in detail according to Ayurveda
To study Diabetes Mellitus in detail according to modern science
To study Lavangadya Churna in detail |
Initial Assessment 0th Day
Follow up on 30th 60th Day
Final Assessment 90th Day |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/01/2026 |
| 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="1"
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
|
Ayurveda is ancient science which helpful in good health promotion, disease prevention, early diagnosis and Treatment of disease. Today is due to life style changing hybridisation of food, high carbohydrate diet, lack of exercise, there is number of people in worldwide and also in India suffer non communicable disease like non-insulin dependent diabetics. In Ayurveda it is correlate with disease madhumeh which is subtype prameh. Madhumeha is explained in many Ancient Samhitas. It is one of the subtypes of Vataja prameha. Acharya Vagbhata describes Prameha as frequent and copious urine with turbidity; i.e. Prabhut avil mutrata . In India Diabetes patient Increases day by day. Diabetes Mellitus is lifestyle related and non-communicable disease. Diabetes Mellitus is a clinically identified by hyperglycaemia due to a deficiency of insulin. Most commonly type I and type II diabetes are seen all over. Type I DM is result of absolute deficiency of insulin while type II DM is due to insulin resistance, Impaired insulin secretion & increased glucose production. Type II is the most common type of diabetes up to 95% of people with diabetes have type II. It usually occurs in middle aged and older people. Patient with diabetes often experience frequent urination (polyuria), increased thirst (polydipsia) and increased hunger (polyphagia). Hence I have selected Lavangadya Churna for study and trial against DM with reference from Bharat Bhaishajya Ratnakar Part 4.So I selected the above said formulation. |