| CTRI Number |
CTRI/2024/10/075641 [Registered on: 22/10/2024] Trial Registered Prospectively |
| Last Modified On: |
16/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Aaragwadha and Guduchi Churna in management of diabetes mellitus(Madhumeha)
|
|
Scientific Title of Study
|
Effect of combination of Aaragwadha and Guduchi Churna verces Haridra
Churna in management of Madhumeha (type II diabetes mellitus): A
randomized controlled trial
|
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vd Narmada Shriram Meshram |
| Designation |
Pg scholar |
| Affiliation |
Shri ayurved mahavidyalaya nagpur |
| Address |
Kayachikitsa department pakwasa samanvay rugnalaya shri ayurved mahavidyalaya hanuman
nagar nagpur maharashtra 440024 India
Nagpur
MAHARASHTRA
440024
India |
| Phone |
7972193851 |
| Fax |
|
| Email |
narmada.meshram97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Archana S Dachewar |
| Designation |
Hod and Professor |
| Affiliation |
Shri ayurved mahavidyalaya nagpur |
| Address |
Kayachikitsa department pakwasa samanvay rugnalaya shri ayurved mahavidyalaya hanuman nagar nagpur maharashtra
440024
India
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9822206312 |
| Fax |
|
| Email |
dr.dachewar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Archana S Dachewar |
| Designation |
Hod and Professor |
| Affiliation |
Shri ayurved aahavidyalaya nagpur |
| Address |
Kayachikitsa department pakwasa samanvay rugnalaya shri ayurved mahavidyalaya hanuman nagar nagpur maharashtra
440024 India
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9822206312 |
| Fax |
|
| Email |
dr.dachewar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kayachikitsa department shri ayurved mahavidyalaya pakwasa Samanvaya rugnalaya hanuman nagar nagpur Maharashtra India 440024 |
|
|
Primary Sponsor
|
| Name |
Dr. Narmada Shriram Meshram |
| Address |
Kayachikitsa Department,Pakwasa Samanavaya Ruganalaya,Shri
Ayurved Mahavidyalaya,Dhanwantari Marg,Hanuman nagar, Nagpur
440024. |
| 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 |
| Vd Narmada Shriram Meshram |
Shri Ayurved Mahavidyalaya, Nagpur |
Kayachikitsa Department,Pakwasa Samanvay
Rugnalaya,Shri Ayurved Mahavidyalaya,Hanuman
Nagar,Dhanwantari marg,Nagpur,440024
Nagpur
MAHARASHTRA |
7972193851
narmada.meshram1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of Shri Ayurved Mahavidyalaya, Nagpur |
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: Combination of aragwadha and guduchi churna, Reference: Sushruta samhita , Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -koshnajala), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Haridra churna, Reference: Bhavprakash nighantu, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: koshnajala ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Newly diagnosed cases of madhumeha who are not on any HGD.
2.Subject with textual signs and symptoms of madhumeha.
3.Subject with fasting sugar between 120-150 mg/dl.
4.Subject with post prandial sugar between 160-250 mg/dl. |
|
| ExclusionCriteria |
| Details |
1.Gestational diabetes.
2.Insulin dependent diabetes mellitus.
3.Subject with complications of DM(type II)
4.Pregnant and lactating women.
5.Patient of type I DM |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the effectiveness of combination of Aaragwadha and Guduchi churna Verces Haridra churna in the reduction of fasting and post prandial blood sugar level in madhumeha(Type II DM)
|
Follow up on 0 15 30 45 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the effectiveness of combination of Aaragwadha & Guduchi churna Verces Haridra churna in the reduction of symptoms such as prabhutmutrata (frequency of micturition) kshudhadhikya (increased in hunger)trushnaadhikya (increased thirst) daurbalyanubhuti (generalized weakness)in Madhumeha (Type II DM)
|
Follow up on 0 15 30 45 days |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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 3 |
|
Date of First Enrollment (India)
|
01/11/2024 |
| 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 Applicable |
| 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
|
In the present study, total 74 participants will be taken for trial dividing them in 2 equal groups.Grp-A will receive the trial drug ’Combination of aragwadha and guduchi churna’ and Grp-B will receive the control drug ’Haridra churna’ twice a day internally for 45 days. Follow up will be taken every 15 days. Result will be concluded based on assessment criteria. |