| CTRI Number |
CTRI/2024/07/070305 [Registered on: 09/07/2024] Trial Registered Prospectively |
| Last Modified On: |
09/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ragi Granola compared to multivitamin in Peri - Menopausal Syndrome |
|
Scientific Title of Study
|
Effect of Ragi Granola in Peri - menopausal syndrome: A Randomized Controlled Pilot Study |
| 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 Vidylaxmi N Aigali |
| Designation |
Post Graduate Scholar |
| Affiliation |
Dr D Y Patil College of ayurved and research centre |
| Address |
Third floor
Departmrnt of Dravyaguns Vigyana
Dr D Y Patil College of ayurved and research centre Pimpri Pune 18.
Third floor
Departmrnt of Dravyaguns Vigyana
Dr D Y Patil College of ayurved and research centre Pimpri Pune 18
Pune
MAHARASHTRA
411018
India |
| Phone |
8496873113 |
| Fax |
|
| Email |
vidyaaigali13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhijeet Shirkande |
| Designation |
Assosciate Professor |
| Affiliation |
Dr D Y Patil College of ayurveda and research centre |
| Address |
Third floor
Departmrnt of Dravyaguns Vigyana
Dr D Y Patil College of ayurved and research centre Pimpri Pune 18
Third floor
Departmrnt of Dravyaguns Vigyana
Dr D Y Patil College of ayurved and research centre Pimpri Pune 18
Pune
MAHARASHTRA
411018
India |
| Phone |
9975253664 |
| Fax |
|
| Email |
abhijeet.shirkande@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhijeet Shirkande |
| Designation |
Assosciate Professor |
| Affiliation |
Dr D Y Patil College of ayurveda and research centre |
| Address |
Third floor
Departmrnt of Dravyaguns Vigyana
Dr D Y Patil College of ayurved and research centre Pimpri Pune 18
Third floor
Departmrnt of Dravyaguns Vigyana
Dr D Y Patil College of ayurved and research centre Pimpri Pune 18
Pune
MAHARASHTRA
411018
India |
| Phone |
9975253664 |
| Fax |
|
| Email |
abhijeet.shirkande@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
| Dr D Y Patil College of ayurved and research centre pimpri, Pune pin code-411018
maharashtra,INDIA |
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
Dr D Y Patil College of ayurved and research centre Pimpri Pune 411018 maharashtra INDIA |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Vidyalaxmi NAigali |
Dr.D.Y.Patil college of ayurved and research centre,pimpri,pune |
dept of kayachikitsa and swastavrutta,striroga evum prasuti opd-5,6,15,7Dr.D.Y.Patil college of ayurved and research centre,pimpri,pune
Pune
MAHARASHTRA |
8496873113
vidyaaigali13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR DYPCA RC INTITUTIONAL ETHICS COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N958||Other specified menopausal and perimenopausal disorders. Ayurveda Condition: ARTAVADOSHAH/ARTAVADUSHTIH/RAJODOSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Ragi granola , Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 30(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -), Additional Information: - | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Multivitamin , Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 30(mg), Frequency: od, Bhaishajya Kal: Antarabhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
AGE- More than 40 years and less than 55 years
Score of 10 or more as per the CCRAS scoring of menopausal syndrome |
|
| ExclusionCriteria |
| Details |
AGE - LESS THAN 40 YEARS AND MORE THAN 55 YEARS
CCRAS menopausal score less than 10
the permanent cessation of periods from past 12 months
cases undergoing treatment for any other serious illness |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to assess the efficacy of ragi granola in management of perimenopausal syndrome |
screening will be done on 20 patients |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of ragi granola in perimenopausal syndrome |
screening will be done on 0 & 15th day
follow ups will be on 15th & 30th days
total duration of the study will be of 30 days |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
21/07/2024 |
| Date of Study Completion (India) |
15/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
15/02/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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 perimenopause is an ill-defined time period that surrounds the final years of a women’s reproductive life.the peri-menopausal syndrome associated with profound reproductive and hormonal changes
It is a randomised controlled pilot study in which treatment(ragi granola) will be carried out on 20 patients of perimenopausal syndrome screening will be done on 0 and 15th day follow ups will be on 15th and 30th days total duration of the study will be of 30 days the age group is taken more than 40 years and less than 55 years
|