| CTRI Number |
CTRI/2023/06/054215 [Registered on: 20/06/2023] Trial Registered Prospectively |
| Last Modified On: |
17/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Trial of Shaladi Churna in the management of Diabetes Mellitus |
|
Scientific Title of Study
|
Randomized controlled trial of “shaladi churna†as an add-on effect in the Management of madhumeha with special reference to diabetes mellitus
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
YOGESH TUKARAM KOTANGALE |
| Designation |
Associate Professor |
| Affiliation |
MAMS Sumatibhai Shah Ayurved College Hadapsar Pune |
| Address |
Opd no 2
First floor
Kayachikitsa department
Malwadi
Hadapsar
Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
09423218193 |
| Fax |
|
| Email |
drytk@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kalyani N Thote |
| Designation |
P.G. student |
| Affiliation |
MAMS Sumatibhai Shah Ayurved College Hdapsar Pune |
| Address |
Opd No 2
First Floor
Kayachikitsa Department
Malwadi
Hadapsar
Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
|
| Fax |
|
| Email |
kalyanithote7026@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kalyani N Thote |
| Designation |
P.G. student |
| Affiliation |
MAMS Sumatibhai Shah Ayurved College Hdapsar Pune |
| Address |
Opd No 2
First Floor
Kayachikitsa Department
Malwadi
Hadapsar
Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
|
| Fax |
|
| Email |
kalyanithote7026@gmail.com |
|
|
Source of Monetary or Material Support
|
| MAMS Sumatibhai Shah Ayurved College Hadapsar Pune |
|
|
Primary Sponsor
|
| Name |
Dr Kalyani Thote |
| Address |
MAMS Sumatibhai Shah Ayurved College Hdapsar Pune |
| 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 Kalyani Thote |
Saneguruji Arogya Kendra |
MAMS
Sumatibhai Shah Ayurved College Hdapsar Pune
Pune
MAHARASHTRA |
7350388787
kalyanithote7026@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: shaladi churna, Reference: Nighantu Ratnakar, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Amalaki Swaras), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Oral hypoglycemic Agent | As prescribed by Physician |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Age group: between 30 years to 60 years.
2) Gender: Male and Female both will be included.
3) A known Diabetic on treatment and newly diagnosed Diabetes.
4) Patient with fasting blood sugar up to 220 mg/dl & post prandial blood sugar upto 300 mg/dl.
5) Patient having HbA1c in between 7 to 9 and Sr. Insulin. |
|
| ExclusionCriteria |
| Details |
1) IDDM, Acromegaly, Cushing’s syndrome and pancreatic disorder.
2) Pregnant and lactating mothers.
3) Patients with K/C/O Nephropathy, Neuropathy and Retinopathy.
4) Patients with gastrointestinal diseases, Liver diseases, tumours, cardio vascular disease, acute myocardial infarction, immune-compromised disease(HIV). |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Glycosylated hemoglobin
Blood Sugar levels
|
at baseline, 4 weeks, 8 weeks and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
Final Enrollment numbers achieved (Total)= "64"
Final Enrollment numbers achieved (India)="64" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/07/2023 |
| Date of Study Completion (India) |
31/10/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
The prevalence of Diabetes Mellitus is rapidly rising through the globe at an alarming rate, where India leads with largest number of diabetics and become Diabetes Capital of the World. Mdhumeha is one of the most common, chronic, aliment. Now a day’s many formulations are described to treat Madhumeha. Among these Shaladi Churna is one of the drug described in Nighanturatnakar. Shaladi Churna having its own properties like Tridoshahar, Agnideepan, Anuloman, Kaphashaman. It possess anti-diabetic effects through their anti-oxidant properties. Shaladi Churna having Medoghna, Mutral properties. The prevalence rate of DM is 14.6. Diabetes is the 6th leading cause of death in India. We have developed newer medicines, but we come across limitations to OHA and Insulin. Hence there is need for Ayurvedic formulations to prevent the complications of DM and to treat the hyperglycemia. Due to sedentary life style people have no time to take Shodhan Chikitsa like Panchakarma. Thus this disease is increases day by day. Considering all above things the study will be carried out in comparison with conventional modern treatment. |