| CTRI Number |
CTRI/2025/08/092963 [Registered on: 13/08/2025] Trial Registered Prospectively |
| Last Modified On: |
12/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of Insomnia as a complication of Madhumeha (Diabetes Mellitus). |
|
Scientific Title of Study
|
A Cross sectional study to assess Insomnia (Nidranash) as a Complication (Upadrava) of Madhumeha with special reference to Athen’s Insomnia Scale. |
| Trial Acronym |
Not applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pavankumar Anant Pidge |
| Designation |
Pg Scholar |
| Affiliation |
PDEAs College of Ayurved and research centre nigadi pune |
| Address |
PDEAs Ayurved Rugnalay and Sterling Multispeciality Hospital Pathology Lab Room no. 115 Sector no. 27 Pradhikaran Nigdi Pune.
PDEAs College of Ayurved And Research Centre Nigdi Pune
PDEAs Ayurved Rugnalay and Sterling Multispeciality Hospital Pathology Lab Room no. 115 Sector no. 27 Pradhikaran Nigdi Pune.
Pune
MAHARASHTRA
411044
India |
| Phone |
7385990930 |
| Fax |
|
| Email |
pavan.pidge7387@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh H Mhaske |
| Designation |
Associate professor |
| Affiliation |
PDEAs College of Ayurved and research centre nigadi pune |
| Address |
PDEAs Ayurved Rugnalay and Sterling Multispeciality Hospital Pathology Lab Room no. 115 Sector no. 27 Pradhikaran Nigdi Pune.
PDEAs College of Ayurved And Research Centre Nigdi Pune
PDEAs Ayurved Rugnalay and Sterling Multispeciality Hospital Pathology Lab Room no. 115 Sector no. 27 Pradhikaran Nigdi Pune.
Pune
MAHARASHTRA
411044
India |
| Phone |
9130805556 |
| Fax |
|
| Email |
dr.rajeshmhaske@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajesh H Mhaske |
| Designation |
Associate professor |
| Affiliation |
PDEAs College of Ayurved and research centre nigadi pune |
| Address |
PDEAs Ayurved Rugnalay and Sterling Multispeciality Hospital Pathology Lab Room no. 115 Sector no. 27 Pradhikaran Nigdi Pune.
PDEAs College of Ayurved And Research Centre Nigdi Pune
PDEAs Ayurved Rugnalay and Sterling Multispeciality Hospital Pathology Lab Room no. 115 Sector no. 27 Pradhikaran Nigdi Pune.
PDEAs College of Ayurved And Research Centre Nigdi Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9130805556 |
| Fax |
|
| Email |
dr.rajeshmhaske@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs college of ayurved and research centre nigadi pune.
Maharashtra India
Pin code-411044 |
|
|
Primary Sponsor
|
| Name |
Not applicable |
| Address |
Not applicable |
| Type of Sponsor |
Other [] |
|
|
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 Pavankumar Anant Pidge |
PDEAs ayurved rugnalaya and Multispeciality hospital nigadi pune |
Pathology Lab Room no. 115 Sector no. 27 Pradhikaran Nigdi Pune.
Pune
MAHARASHTRA |
7385990930
pavan.pidge7387@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee,PDEAS College of Ayurved and Research Centre, Sector No. 25, Pradhikaran Nigdi, Pune. |
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 |
|
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age group between 40-60years.
Diagnosed patients of madhumeha (diabetes mellitus).
Person having madhumeha (diabetes mellitus) for more than 5 years.Patient will be selected Irrespective of their Gender, religion, socioeconomical class and marital status. |
|
| ExclusionCriteria |
| Details |
known cases of chronic kidney diseases, malignancies and major illnesses like Chronic Obstructive Pulmonary Diseases, known cases of Alzheimer disease will be excluded.known cases of any psychomotor disorders, on antidepressants medications, on sleeping pills will be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| A Cross sectional study to assess Insomnia (Nidranash) as a Complication (Upadrava) of Madhumeha with special reference to Athen’s Insomnia Scale. |
One day |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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
|
N/A |
|
Date of First Enrollment (India)
|
25/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/08/2025 |
| 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
|
1)Title - A Cross sectional study to assess Insomnia (Nidranash) as a Complication (Upadrava) of Madhumeha with special reference to Athen’s Insomnia Scale. 2)Primary Objective –To assess insomnia (Nidranash) as a complication (Upadrava) of Madhumeha with special reference to Athen’s Insomnia Scale.
3)Methodology - 1) APPROPRIATE STUDY DESIGN –It is a Cross Sectional study. 2) STUDY SETTING – A) STUDY PLACE- OPD and IPD in concern institutional hospitals. B) STUDY DURATION –18 Months C) STUDY POPULATION-Diagnosed patients of madhumeha of age group of 40-60 years.
4)Sample size -90 diagnosed patients of madhumeha
5)APPROPRIATE SAMPLING TECHNIQUE – Purposive sampling technique will be taken.
6)METHOD OF SELECTION OF STUDY SUBJECT INCLUSION CRITERIA – • Age group between 40-60years. Diagnosed patients of madhumeha (diabetes mellitus). Person having madhumeha (diabetes mellitus) for more than 5 years. Patient will be selected Irrespective of their Gender, religion, socioeconomical class and marital status.
EXCLUSION CRITERIA – known cases of chronic kidney diseases, malignancies and major illnesses like Chronic Obstructive Pulmonary Diseases, known cases of Alzheimer disease will be excluded. known cases of any psychomotor disorders, on antidepressants medications, on sleeping pills will be excluded.
|