| CTRI Number |
CTRI/2024/07/070739 [Registered on: 16/07/2024] Trial Registered Prospectively |
| Last Modified On: |
12/07/2024 |
| 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
|
A Comparative Clinical Study to evaluate the efficacy of vangashilajatu and nishaamalaki in the management of Madhumeha(Type 2 Diabetes Mellitus) |
|
Scientific Title of Study
|
An Open Labelled Parallel Comparative Clinical Study to evaluate the efficacy of Vangashilajatu and Nishaamalaki in the management of Madhumeha with special reference to Type 2 Diabetes Mellitus. |
| 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 Himani Bhardwaj |
| Designation |
Post-Graduation Student |
| Affiliation |
Institute for Ayurved Studies and Research |
| Address |
Room no- 79, Department of Kayachikitsa,Institute for Ayurved Studies and Research, SKAU,Sec-8,Umri Road,Kurukshetra,136118
Institute for Ayurved Studies and Research, SKAU,Sec-8,Umri Road,Kurukshetra,136118
Kurukshetra
HARYANA
136118
India |
| Phone |
7988200276 |
| Fax |
|
| Email |
bhardwajh7988@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Neelam Kumari |
| Designation |
Professor and Chairperson |
| Affiliation |
Institute for Ayurved Studies and Research |
| Address |
Room no-56, Department of kayachikitsa, Institute for Ayurved Studies and Research, SKAU,Sec-8,Umri Road,Kurukshetra,136118
Institute for Ayurved Studies and Research, SKAU,Sec-8,Umri Road,Kurukshetra,136118
Kurukshetra
HARYANA
136118
India |
| Phone |
9671368058 |
| Fax |
|
| Email |
mehranilam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Himani Bhardwaj |
| Designation |
Post-Graduation Student |
| Affiliation |
Institute for Ayurved Studies and Research |
| Address |
Room no- 79, Department of Kayachikitsa, Institute for Ayurved Studies and Research, SKAU,Sec-8,Umri Road,Kurukshetra,136118
Institute for Ayurved Studies and Research, SKAU,Sec-8,Umri Road,Kurukshetra,136118
Kurukshetra
HARYANA
136118
India |
| Phone |
7988200276 |
| Fax |
|
| Email |
bhardwajh7988@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Ayurved Studies and Research, SKAU,Sec-8,Umri Road,Kurukshetra,136118 |
|
|
Primary Sponsor
|
| Name |
Institute for Ayurved Studies and Research |
| Address |
Sec-8,Umri Road, Kurukshetra, 136118 |
| Type of Sponsor |
Government medical college |
|
|
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 Himani Bhardwaj |
Institute For Ayurved Studies and Research |
Room no 56, department of Kayachikitsa, Institute For Ayurved Studies and Research, Shri Krishna Ayush University
Sector 8, Umri Road, Kurukshetra
Kurukshetra
HARYANA |
7988200276
bhardwajh7988@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Shri Krishna Ayush University,Kurukshetra |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E08-E13||Diabetes mellitus. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Nishaamalaki, Reference: Astang Hriday, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Jal), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vangashilajatu, Reference: Yogaratnakar, Route: Oral, Dosage Form: Bhasma, Dose: 375(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Jal), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Willing for clinical trials and ready to give written consent.
2.Patients with age between 25-60 years of either sex.
3.Patients possessing signs and symptoms of Prameha (Diabetes Mellitus).
4.Freshly diagnosed & confirmed cases of Madhumeha on the basis of Diagnostic criteria for diabetes.
5.FBS-126-200 mg/dl and PPBS-200-300 mg/dl
6. HbA1c 6.5%-8%
|
|
| ExclusionCriteria |
| Details |
1. Patients not willing for the clinical trail.
2. Patients not fulfilling the inclusion criteria
3. Patients below the age of 25 years and above the age of 60 years.
4. Fasting blood sugar level less than 126mg/dl and greater than 200 mg/dl, post prandial blood sugar level less than 200mg/dl and greater than 300 mg/dl, HbA1C less than 6.5 percentage and greater than 8 percentage
5. Insulin dependent Diabetes mellitus(IDDM), gestational Diabetes, MODY, LADA.
6. Endocrinopathies.
7. Pregnant ladies and lactating mothers |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of Vangashilajatu in comparison to Nishaamlaki by applying appropriate statistical tools in the management of Madhumeha |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1- Reduction in scoring pattern of sign and symptoms of Madhumeha
2- Improvement and management of blood sugar level and other hematological parameters
3- Help to live diabetic patients without complications |
28 days |
|
|
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)
|
05/08/2024 |
| 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
|
Diabetes
Mellitus has become one of the most alarming health problems of this world
because of its devastating consequences. With largest number of Diabetic
patients,India has been termed as "The Diabetic capital of the worldâ€. Madhumeha
is a type of Vataj Prameha and is also final stage of all Pramehas
if left untreated. The Patient passes
large quantity of urine which is Kashaya, Madhura, Pandu & Ruksha.
Madhumeha shows close resemblance of
characteristic features to T2DM. DM is a metabolic disorder and is
characterized by increase in blood glucose level, deficiency of insulin or resistance to
insulin. So a study will be conducted with the aim to compare the efficacy of Vangashilajatu
& Nishaamalaki in the
management of Madhumeha for which 60 patients will be randomly selected and divided into 2 groups.
In group A (30 patients) 1 cap Vangashilajatu will be given twice 15 min before meal with water and
In group B (30 patients) 3 g Nishaamalaki
powder will be given 15 min before meal
with water for 28 days. Patients will be we regularly followed up at interval of
7 days during treatment & 2 follow ups will be scheduled at interval of 14 days after
treatment. Clinical features & laboratory investigation will be analysed
during & after the treatment. Results will be analysed in accordance with
the appropriate statistical tests. |