| CTRI Number |
CTRI/2025/04/085930 [Registered on: 29/04/2025] Trial Registered Prospectively |
| Last Modified On: |
23/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Understanding the principle of nidan parivarjan with a focus on diabetes |
|
Scientific Title of Study
|
Evaluation of Nidan Parivarjan Siddhant with special reference to Madhumeha |
| 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 Ambrish Mishra |
| Designation |
Junior resident |
| Affiliation |
Banaras Hindu University |
| Address |
Department of siddhant darshan IMS BHU Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
09415361140 |
| Fax |
|
| Email |
Ambrishmishra1234@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof CS Pandey |
| Designation |
Former head of department |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Siddhant darshan IMS BHU Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
09415361140 |
| Fax |
|
| Email |
cspandey@bhu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ambrish Mishra |
| Designation |
Junior resident |
| Affiliation |
Banaras Hindu University |
| Address |
Department of siddhant darshan IMS BHU Varanasi
UTTAR PRADESH
221005
India |
| Phone |
09415361140 |
| Fax |
|
| Email |
Ambrishmishra1234@gmail.com |
|
|
Source of Monetary or Material Support
|
| sir sunderlal hospital faculty of Ayurveda Institute of Medical sciences BHU Varanasi 221005 uttar pradesh India |
|
|
Primary Sponsor
|
| Name |
Faculty of Ayurveda IMS BHU |
| Address |
Department of Siddhant Darshan, Faculty of Ayurveda, IMS BHU varanasi 221005 uttar pradesh India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| prof cs pandey |
Department of Siddhant darshan, Faculty of Ayurveda, IMS BHU Varansi |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ambrish Mishra |
Sir Sunderlal Hospital BHU |
OPD No 11A, Siddhant Darshan OPD
Department of Siddhant Darshan Faculty of Ayurveda IMS BHU Varanasi UTTAR PRADESH
Varanasi
UTTAR PRADESH |
08574729954
Ambrishmishra1234@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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Amlaki, Reference: Charak samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Haridra, Reference: charak chikitsa, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
. Patients who are having cardinal symptoms of Madhumeha as described in Ayurvedic texts.
. All patients of Type 2 DM (Non insulin dependent).
. patients who have given informed consent
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Based on subjective and objective criteria
Madhusamam Mutram
Pipasadhikya
Kara-Pada-Suptanga
Swedaadhikya
Alasya
Jatilibhavam kesheshu
Asyamadhurya
Karapadayodaha
Blood investigations- FBS(fasting blood sugar), PPBS(post prandial blood sugar), HbA1C
Urine examination- Routine examination, Microscopic examination
|
3 follow ups with equal interval of 1 month
Total study time will be 3 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| B. This study will signify the preventive aspects of Madhumeha as well as will also help in management and reduce the chances of complications in Madhumeha |
After giving medication, 3 follow up of 4 weeks will be done.
Total study time will be 3 months
|
|
|
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 |
|
Date of First Enrollment (India)
|
02/05/2025 |
| 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="0"
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
|
The impact of Nidana Parivarjana in the management of Madhumeha as well as
the complementary effects of the same to the pharmacological interventions in Madhumeha
will be ascertained within the limitations of the study. This in turn can
reduce the over dependence on of existing healthcare system and medicines can
help a great deal in framing the present-day Diabetes treatment, with cost
effective |