| CTRI Number |
CTRI/2025/12/099085 [Registered on: 15/12/2025] Trial Registered Prospectively |
| Last Modified On: |
11/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Link between Female Sexual Dysfunction and Mental Health |
|
Scientific Title of Study
|
A Cross-Sectional Survey Study on association of Klaibya (Sexual Dysfunction) with Chintayanam Cha Atichintanat (Anxiety) in Women of Reproductive Age Using FSFI, DASS-21 and AAA |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Samriti |
| Designation |
PG Scholar |
| Affiliation |
Shri Dhanwantry Ayurvedic College and Hospital Sector 46 B Chandigarh |
| Address |
Department of Rog Nidana Evum Vikriti Vigyana Shri Dhanwantry Ayurvedic College and Hospital Sector 46 B Chandigarh
Chandigarh
CHANDIGARH
160047
India |
| Phone |
9813668975 |
| Fax |
|
| Email |
samritisaini2810@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rijin Mohan |
| Designation |
Associate Professor |
| Affiliation |
Shri Dhanwantry Ayurvedic College and Hospital Sector 46 B Chandigarh India |
| Address |
Department of Rog Nidana Evum Vikriti Vigyana Shri Dhanwantry Ayurvedic College and Hospital Sector 46 B Chandigarh India
Chandigarh
CHANDIGARH
160047
India |
| Phone |
9496463399 |
| Fax |
|
| Email |
drrijinm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Samriti |
| Designation |
PG Scholar |
| Affiliation |
Shri Dhanwantry Ayurvedic College and Hospital Sector 46 B Chandigarh |
| Address |
Department of Rog Nidana Evum Vikriti Vigyana Shri Dhanwantry Ayurvedic College and Hospital Sector 46 B Chandigarh
Chandigarh
CHANDIGARH
160047
India |
| Phone |
9813668975 |
| Fax |
|
| Email |
samritisaini2810@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Shri Dhanwantry Ayurvedic College and Hospital |
| Address |
Sector 46 B Chandigarh 160047 |
| 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 |
| Samriti |
Shri Dhanwantry Ayurvedic College and Hospital |
Department of Rog Nidana Evum Vikriti Vigyana Shri Dhanwantry Ayurvedic College and Hospital Sector 46 B Chandigarh
Chandigarh
CHANDIGARH |
9813668975
samritisaini2810@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shri Dhanwantry Ayurvedic College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
nil |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Sexually active
Willing to participate in study |
|
| ExclusionCriteria |
| Details |
Menopausal women
Pregnant women
Lactating women with less than 8 weeks after their childbirth
Women diagnosed with any independent sexual disorder
Women with known psychiatric disorder
Chronic medical illness such as Diabetes, Hypertension etc.
Substance abuse |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
There is prevalence of Klaibya in the women of reproductive age, associated with
Atichintanat. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| External validity of AAA with DASS (Anxiety domain) exists. |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
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)
|
01/01/2026 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 a cross-sectional survey study with sample size of 105 sexually active women aged 18 to 45 years. The primary aim is to evaluate the association between Klaibya (Sexual Dysfunction) and Chintayanam Cha Atichintanat (Anxiety) in this population. Subjective assessment will use the Female Sexual Function Index (FSFI) for Klaibya, and the Ayurveda Assessment Scale for Anxiety (AAA) and Depression Anxiety Stress Scale (DASS-21) for Chintayanam Cha Atichintanat. Objective correlation will be established by measuring Serum DHEAS and Serum Cortisol levels. The study is designed to explore the psycho-sexual health correlation from both modern and Ayurvedic perspectives and may help revalidate the concepts mentioned in Ayurvedic texts. |