| CTRI Number |
CTRI/2025/09/094804 [Registered on: 15/09/2025] Trial Registered Prospectively |
| Last Modified On: |
12/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Creating a Scale to Understand Normal Period Health and How It Relates to Women’s Body Types |
|
Scientific Title of Study
|
Development And Standardization of Suddha Artava Scale And Its Association With Prakriti Among Healthy Female Volunteers |
| 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 Ekta |
| Designation |
PhD Scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
OPD No.26 PG department of prasuti Tantra evam Stri Roga ,National Institute of Ayurveda,Jaipur,Jorawar singh Gate
OPD No.26 PG department of prasuti Tantra evam Stri Roga ,National Institute of Ayurveda,Jaipur,Jorawar singh Gate
Jaipur
RAJASTHAN
303603
India |
| Phone |
07691892326 |
| Fax |
|
| Email |
pushpalathania@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.B.Pushpalatha |
| Designation |
Professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
OPD No.26 PG department of prasuti Tantra evam Stri Roga ,National Institute of Ayurveda,,Jorawar singh Gate,Jaipur,Rajasthan(India)
Jaipur
RAJASTHAN
302002
India |
| Phone |
07691892326 |
| Fax |
|
| Email |
pushpalathania@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ekta |
| Designation |
PhD Scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
OPD No.26 PG department of prasuti Tantra evam Stri Roga ,National Institute of Ayurveda,Jaipur,Jorawar singh Gate
OPD No.26 PG department of prasuti Tantra evam Stri Roga ,National Institute of Ayurveda,Jaipur,Jorawar singh Gate
Jaipur
RAJASTHAN
302002
India |
| Phone |
07691892326 |
| Fax |
|
| Email |
ektay913@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda,Jorawar singh Gate,amer road,Jaipur,302002,Rajasthan,India |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda,Jaipur |
| Address |
National Institute of Ayurveda,Jorawar Singh Gate ,Amer Road,Jaipur,Rajasthan 302002 |
| 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 |
| DrEkta |
National Institute of Ayurveda(De Novo) Jaipur |
OPD NO. 26 ,PG department of Prasuti Tantra evum Stri Roga National Institute of Ayurveda,Jorawar Singh Gate ,Amer Road,Jaipur,Rajasthan 302002
Jaipur
RAJASTHAN |
07691892326
ektay913@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTE NATIONAL INSTITUTE OF AYURVEDA Deemed To be university(De-Novo)JorawarsinghGate,AmerRoad,Jaipur-302002(Raj.),India,J |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Not Applicable |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Collection of menstrual blood | (Procedure Reference: , Procedure details: Collection of Menstrual blood on 2nd day of Menstrual cycle by means of Menstrual cup)
|
|
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1)Apparently healthy female volunteers of Age between 18-35 years 2)Having menstrual bleeding phase of 3-7 days 3)With menstrual cycle interval of one month (28-30 days) 4)Regular and Normal Menstrual cycle for 3 months. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Development and standardization of Suddha Artava scale in healthy female Volunteers. |
one time observation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Variations in Shuddha Artava in healthy female Volunteers of different prakriti. |
One time observation |
|
|
Target Sample Size
|
Total Sample Size="115"
Sample Size from India="115"
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)
|
15/01/2026 |
| 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="2"
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
|
The proposed study focuses on the development and standardization of a Shuddha Artava scale and its association with prakriti among healthy female volunteers. Menstruation is an important physiological process and Ayurveda describes various physical characteristics of menstrual blood that reflect reproductive health. Currently, there is no standardized scale to identify Shuddha Artava, hence this study aims to create one and analyze its variations according to prakriti. The research will be a cross sectional clinico analytical study conducted at the National Institute of Ayurveda Jaipur with 115 healthy female volunteers aged 18 to 35 years. The study will be carried out in two phases, first developing and standardizing the Shuddha Artava scale, and second analyzing variations in relation to prakriti. The physical characteristics such as colour, odour, texture, staining, volume and pH of menstrual blood will be assessed. Prakriti analysis will be done using the CCRAS Prakriti portal. Serum FSH, LH and CRP will also be evaluated. The primary objective is to establish a reliable standardized scale for Shuddha Artava, while the secondary objective is to assess variations among different prakriti. Statistical analysis will include descriptive statistics and chi square test. The outcomes will help in diagnosing Shuddha Artava and understanding its association with prakriti. The study is expected to provide a non invasive tool for reproductive health assessment and will be carried out over 30 months after IEC and CTRI approval. |