| CTRI Number |
CTRI/2026/02/104333 [Registered on: 19/02/2026] Trial Registered Prospectively |
| Last Modified On: |
19/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Effectiveness of Uttara Basti in the Management of Female Infertility – A Survey Study |
|
Scientific Title of Study
|
Effectiveness of uttar basti in the managemnt of female infertility-a survey 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 |
SWATHI C |
| Designation |
Associate Professor |
| Affiliation |
sri jayendra saraswathi ayurveda college and hospital |
| Address |
Department of Stree Roga and Prasuti Tantra
Sri Jayendra Saraswathi Ayurveda College and Hospital Chennai ,Bangalore highway , Nazarathpet , Chennai . Chennai TAMIL NADU 600123 India |
| Phone |
8105774944 |
| Fax |
|
| Email |
drswathi@sjsach.org.in |
|
Details of Contact Person Scientific Query
|
| Name |
SWATHI C |
| Designation |
Associate Professor |
| Affiliation |
sri jayendra saraswathi ayurveda college and hospital |
| Address |
Department of Stree Roga and Prasuti Tantra
Sri Jayendra Saraswathi Ayurveda College and Hospital Chennai ,Bangalore highway , Nazarathpet , Chennai . Chennai TAMIL NADU 600123 India |
| Phone |
8105774944 |
| Fax |
|
| Email |
drswathi@sjsach.org.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Amrutha BS |
| Designation |
Assistant Professor |
| Affiliation |
sri jayendra saraswathi ayurveda college and hospital |
| Address |
Department of Stree roga and Prasuti Tantra
Sri Jayendra Saraswathi Ayurveda College and Hospital Chennai ,Bangalore highway , Nazarathpet , Chennai . Chennai TAMIL NADU 600123 India |
| Phone |
9562294840 |
| Fax |
|
| Email |
dramruthabs@sjsach.org.in |
|
|
Source of Monetary or Material Support
|
| Sri Chandrasekharendra Saraswathi Viswa Mahavidyalaya (SCSVMV University) |
|
|
Primary Sponsor
|
| Name |
SCSVMV Research and Development Cell University Funded Minor Research Project UFMRP |
| Address |
Sri Jayendra Saraswathi Street Enathur , Kanchipuram-631561 |
| Type of Sponsor |
Research institution |
|
|
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 SWATHI C |
Sri Jayendra Saraswathi Ayurveda College and Hospital |
PG Department of Stree Roga and Prasuti Tantra
Chennai-Bangalore Highway Nazarathpet Chennai Tamil Nadu Thiruvallur TAMIL NADU |
8105774944
drswathi@sjsach.org.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sri Jayendra Saraswathi Ayurveda College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Female infertility — study focuses on documenting clinical practices of Uttara Basti used in its management by Prasuti Tantra & Stri Roga practitioners. |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
prasuti Tantra and stri roga practitioners
Practicing Uttara Basti procedure |
|
| ExclusionCriteria |
| Details |
Other specialization
Non-practicing specialists
Incomplete survey responses |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome assessed will be the pattern and extent of procedural variations in the administration of Uttara Basti (vaginal and uterine routes) among Prasuti Tantra & Stri Roga practitioners, as documented through responses to a structured survey questionnaire. This includes variations in indications, drug selection, dose/quantity, timing within menstrual cycle, number of sittings, instrumentation, aseptic measures, and procedural steps. |
This outcome will be assessed once at the time of questionnaire completion by each participant during the study recruitment period, with aggregated analysis performed at the end of the 6-month data collection phase. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Types of instruments and formulations used
Perceived efficacy and safety
Complications reported
Practitioner-reported improvement rates |
6 months |
|
|
Target Sample Size
|
Total Sample Size="250" Sample Size from India="250"
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)
|
01/04/2026 |
| 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) |
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
|
Uttara Basti is an important Ayurvedic therapeutic procedure widely used in the management of female infertility. However, considerable variation exists in its clinical administration across practitioners with respect to route of administration (vaginal or intra-uterine), type of medicated formulations, instruments used, procedural steps, and treatment intervals. This cross-sectional survey study aims to document the current practices of Uttara Basti among Prasuti Tantra and Stri Roga practitioners across India and to evaluate practitioner-perceived efficacy and safety of different approaches. Data will be collected from approximately 250 postgraduate qualified practitioners using a structured online questionnaire distributed through professional networks. Information regarding procedural methods, preparatory and post-procedure measures, complications, and clinical outcomes will be analysed descriptively to identify common trends and variations. Based on the findings, the study intends to develop an evidence-informed standardized procedural framework for academic and clinical use. The results of this study are expected to support safer practice, improve procedural consistency, and contribute to strengthening integrative reproductive healthcare guidelines within Ayurveda. |