| CTRI Number |
CTRI/2025/06/089646 [Registered on: 26/06/2025] Trial Registered Prospectively |
| Last Modified On: |
16/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
ANALYSIS THE ETIOLOGY AND EFFECT OF NIDAN PARIVARJANA ALONG WITH PATHYA PALANA IN MADHUMEHA ROGI W.S.R. TO DIABETES MELLITUS |
|
Scientific Title of Study
|
OBSERVATIONAL STUDY TO ANALYSE THE ETIOLOGY AND EFFECT OF NIDAN PARIVARJANA ALONG WITH PATHYA PALANA IN MADHUMEHA ROGI W.S.R. TO DIABETES MELLITUS IN THE PERSPECTIVE OF SVABHAAVOPARAMAVAAD. |
| 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 RAJKIRAN ARYA |
| Designation |
M.D. Scholar |
| Affiliation |
Madan Mohan Malviya Government Ayurved College, Udaipur |
| Address |
PG Department of Ayurved Samhita And Siddhant Madan Mohan Malviya Government Ayurved College Radaji Choraha Udaipur
313001
RAJASTHAN
PG Department of Ayurved Samhita And Siddhant Madan Mohan Malviya Government Ayurved College Radaji Choraha Udaipur
313001
RAJASTHAN
Udaipur
RAJASTHAN
313001
India |
| Phone |
9887728930 |
| Fax |
|
| Email |
rajkieanarya1989@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MAHESH GUPTA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Madan Mohan Malviya Government Ayurved College, Udaipur |
| Address |
PG Department of Ayurved Samhita And Siddhant Madan Mohan Malviya Government Ayurved College Radaji Choraha Udaipur
RAJASTHAN
313001
India
PG Department of Ayurved Samhita And Siddhant Madan Mohan Malviya Government Ayurved College Radaji Choraha Udaipur
RAJASTHAN
313001
India
Udaipur
RAJASTHAN
313001
India |
| Phone |
9829070181 |
| Fax |
|
| Email |
MKGUPTA98290@GMAIL.COM |
|
Details of Contact Person
Public Query
|
| Name |
DR MAHESH GUPTA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Madan Mohan Malviya Government Ayurved College, Udaipur |
| Address |
PG Department of Ayurved Samhita And Siddhant Madan Mohan Malviya Government Ayurved College Radaji Choraha Udaipur
RAJASTHAN
313001
India
PG Department of Ayurved Samhita And Siddhant Madan Mohan Malviya Government Ayurved College Radaji Choraha Udaipur
RAJASTHAN
313001
India
Udaipur
RAJASTHAN
313001
India |
| Phone |
9829070181 |
| Fax |
|
| Email |
MKGUPTA98290@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Madan Mohan Malviya Government Ayurved College |
| Address |
Madan Mohan Malviya Government Ayurved College Radaji Choraha
Udaipur Rajasthan 313001 India |
| 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 Rajkiran arya |
Rajvaidya prem shankar sharma rajkiya ayurved chikitshalya |
PG Department of Ayurved Samhita And Siddhant Madan Mohan Malviya Government Ayurved College Radaji
Choraha Udaipur
Rajasthan
313001
India
Udaipur
RAJASTHAN |
9887728930
rajkieanarya1989@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee MMM Government ayurved college udaipur rajasthan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E00-E89||Endocrine, nutritional and metabolic diseases. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Lifestyle | - | - | Dinacarya: Apatyanimittaja Madhumeha , AaBrahma Muhurta atiJagarana,avyayam , atibhojya, divashyana , Ritucarya: aa sanshodhan, Acara Rasayana:, Other:, Pathya/Apathya:, Pathya:, Apathya: | | 2 | Intervention Arm | Lifestyle | - | - | Dinacarya: Brahma
Muhurta
Jagarana
Ushah
Pana
Vyayama
Padagamana
Prathana
Snana
Alpahara
Hastapada
Prakshalana
Laghu
bhojana
Annavarga
Java
Millets
Bajra
Ragi
Kulattha
Mudga
Chanaka
Adhaki
Sarshapa
taila
Shuskaanna
Laja
Dhani
Daliya
Saktu
Bhune
Yava
Jwar
Chanka
Shakavarga
Patola
Methika
Karvellaka
Dadima
Amlaki
Maricha
Saindhava
Hingoo
Upavishana
Vajrasana
in
Phalavarga
Amlaki, Dadima(Anar) or Jambu or Yusha (steam boiled soup)
Dinner
Anna
Shaka
Yusha
Padagamanam
Prathana
Dhyana
Nidra
Apatarpana, Ritucarya: accordnig to classical text books, Acara Rasayana:, Other:, Pathya/Apathya:yes, Pathya:Shakavarga
Patola
Methika
Karvellaka
Dadima
Amlaki
Maricha
Saindhava
Hingoo, Apathya:viruddha ahar, garisth ahar, diwasawapn, gurh vaikit ahar, navanna, dadhi audak mans etc |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed cases of DM who visit in o.p.d and general health camps
Patient presenting with classical sign and symptoms of Madhumeha
Blood sugar level - FBS -100mg/dl to 125mg/dl
PPBS- 140 mg/dl to 199 mg/dl HBA1c-5.7% TO 6.4% Prediabetic patients and without any medical intervention
|
|
| ExclusionCriteria |
| Details |
1. Patient present with any other metabolic disorder like Gaucherdisease, Phenylketonuria, galactosemic, PraderWillis Syndromeetc.
2. Patient present with any other endocrine disorders like Hypothyroidism,Acromegaly, Addisons disease, Cushing syndrome etc.
3. Patient present with any other congenital(EXCEPT MADHUMEHA), hereditary disease(EXCEPT MADHUMEH) and serious illness.
4. Patient present with IDDM, complex DM, already having treatment of DM and diabetic ulcer.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| the significant confirmative Nidana (Cause) and established Svabhaavoparamavaad sidhant with follow Nidan Parivarjan and Pathya Palan in Madhumeha. |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| By Nidana Parivarjan & Pathya Palan can impoved quality of life in Madhumeha patient |
90 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)
|
08/07/2025 |
| 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="0"
Months="3"
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
|
THIS IS AN OBSERVATIONAL STUDY TO ANALYSE THE ETIOLOGY AND EFFECT OF NIDAN PARIVARJANA ALONG WITH PATHYA PALANA IN MADHUMEHA ROGI W.S.R. TO DIABETES MELLITUS IN THE PERSPECTIVE OF SVABHAAVOPARAMAVAAD. |