| CTRI Number |
CTRI/2024/05/066728 [Registered on: 03/05/2024] Trial Registered Prospectively |
| Last Modified On: |
06/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Rasa Vruddhikara Ahara] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Relation of Rasa Dhatu and Menstrual flow in Healthy Women |
|
Scientific Title of Study
|
An Interventional Study of Correlation between Status of Rasa Dhatu and Rajapravritti in Different Dehaprakriti |
| 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 Janki Bopaliya |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
105 Ground floor Kriya Sharir Department Parul Institute of Ayurved Parul University Limda Vadodara Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
6351286348 |
| Fax |
|
| Email |
jankibopaliya34@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vaidehi V Raole |
| Designation |
Professor |
| Affiliation |
Parul Institute Of Ayurved |
| Address |
105 Ground floor Kriya Sharir Department Parul Institute of Ayurved
Parul University Limda Vadodara GUJARAT
Vadodara
GUJARAT
391760
India |
| Phone |
9824284371 |
| Fax |
|
| Email |
vaidehi.raole@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaidehi V Raole |
| Designation |
Professor |
| Affiliation |
Parul Institute Of Ayurved |
| Address |
105 Ground floor Kriya Sharir Department Parul Institute of Ayurved Parul University Limda Vadodara Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9824284371 |
| Fax |
|
| Email |
vaidehi.raole@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| 105 Ground floor Kriya Sharir Department Parul Institute of Ayurved Parul University Limda Vadodara Gujarat, India 391760 |
|
|
Primary Sponsor
|
| Name |
Parul Institute Of Ayurved |
| Address |
105 Ground floor Kriya Sharir Department Parul Institute of Ayurved
Parul University Limda Vadodara GUJARAT 391760
India
|
| Type of Sponsor |
Private 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 Janki Bopaliya |
Parul Institute Of Ayurved and Hospital |
105 Ground floor Kriya
Sharir Department
Parul Institute of
Ayurved Parul
University Limda Vadodara
GUJARAT 391760
India
Vadodara
GUJARAT |
6351286348
jankibopaliya34@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Parul Institute of Ayurved- Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: Is not Required, Ritucarya: Is not Required, Acara Rasayana:Is not Required, Other:Advise Rasa Vruddhikara Ahara in Rasa Kshaya person , Pathya/Apathya:yes, Pathya:Advise Rasa Vruddhikara Ahara , Apathya:Not Required |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
Apparently Healthy Female Volunteers Irrespective of any caste and religion
Age between 18 to 30 years, those females who are in Menstrual phase of life |
|
| ExclusionCriteria |
| Details |
Individuals have any diagnosed systemic disorders and on medication.
Female Individual on any Hormonal Treatment
Pregnancy and Lactation
Patients using IUCD
Hysterectomy or TL done |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| There will be significant effect of Rasa Dhatu Vruddhikara Diet in Rasa Dhatu Kshaya person |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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
Modification(s)
|
Phase 1 |
|
Date of First Enrollment (India)
|
01/06/2024 |
| 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="0"
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
|
Proper Rajapravritti (Menstrual cycle) is one of the essential factors for female reproductive health. Upadhatu of Rasa Dhatu is Rajas. Due to change in life style, Rajapravritti seen Disturbed. so proper nourishment of Rasa Dhatu is essential for Normal Rajapravritti. so the study is aimed to establish the correlation between status of Rasa Dhatu and Rajapravritti. |