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CTRI Number  CTRI/2025/12/099361 [Registered on: 17/12/2025] Trial Registered Prospectively
Last Modified On: 17/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Evaluation of Uterine Biophysical Profile to assess the efficacy of Uttarbasti among Unexplained Infertility. 
Scientific Title of Study   Evaluation of Uterine Biophysical Profile to assess the efficacy of Uttarbasti among Unexplained Infertility. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Namrata Tambe 
Designation  Assistant Professor 
Affiliation  Bharati vidyapeeth college of Ayurved pune 
Address  Bharati Vidyapeeth (Deemed to be University) Ayurved Hospital, OPD no. 10 Prasuti tantra avum streevrog dept, Dhankawadi Pune- 411043

Pune
MAHARASHTRA
411043
India 
Phone  9561683993  
Fax    
Email  namrata.tambe4@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Namrata Tambe 
Designation  Assistant Professor 
Affiliation  Bharati vidyapeeth college of Ayurved pune 
Address  Bharati Vidyapeeth (Deemed to be University) Ayurved Hospital, OPD no. 10 Prasuti tantra avum streevrog dept, Dhankawadi Pune- 411043

Pune
MAHARASHTRA
411043
India 
Phone  9561683993  
Fax    
Email  namrata.tambe4@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Namrata Tambe 
Designation  Assistant Professor 
Affiliation  Bharati vidyapeeth college of Ayurved pune 
Address  Bharati Vidyapeeth (Deemed to be University) Ayurved Hospital, OPD no. 10 Prasuti tantra avum streevrog dept, Dhankawadi Pune- 411043

Pune
MAHARASHTRA
411043
India 
Phone  9561683993  
Fax    
Email  namrata.tambe4@gmail.com  
 
Source of Monetary or Material Support  
Bharati Vidyapeeth (Deemed to be University) College of Ayurved,Dhankawadi Pune  
 
Primary Sponsor  
Name  Bharati Vidyapeeth (Deemed to be University) College of Ayurved, Pune 
Address  Bharati Vidyapeeth (Deemed to be University) College of Ayurved,Dhankawadi Pune  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Namrata Tambe  Bharati Vidyapeeth (Deemed to be University) Ayurved Hospital,Dhankawadi Pune  Bharati Vidyapeeth (Deemed to be University) Ayurved Hospital, OPD no. 10 Prasuti tantra avum streevrog dept, Dhankawadi Pune- 411043
Pune
MAHARASHTRA 		 09561683993

namrata.tambe4@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE(BV(DU)COA-IEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N979||Female infertility, unspecified. Ayurveda Condition: VANDHYA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-उत्तरबस्ती (Procedure Reference: Sushruta Saṃhitā, Chikitsā Sthāna 38/13–14., Procedure details: • Lithotomy position with head low position. • Painting betadine solution and draping. • Per-vaginal examination • Per-speculum examination • Catch cervix with vulsellum. • Infant feeding tube should slowly and gradually be inserted • Push Medicine slowly at a rate of 0.5cc every 2 minutes. • Gradually, the feeding tube and speculum should be removed. )
(1) Medicine Name: Phala Ghruta, Reference: Aṣṭāṅga Hṛdaya – Uttara Tantra 36/69–71 (Vandhyatva Chikitsā), Route: Vaginal, Dosage Form: Ghrita, Dose: 5(ml), Frequency: od, Duration: 5 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1. Women aged between 20-40 years.
2. Women unable to conceived since last 1 year in spite of having regular sexual contact.
3. Individuals diagnosed with unexplained infertility.
4. Consent to participate in the study.
 
 
ExclusionCriteria 
Details  1. Pregnant women
2. Women with a miscarriage in last one year.
3. Women with severe hormonal imbalances or undergoing hormonal therapy in last one year.
4. Individuals with any underlying chronic conditions hypertension.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the efficacy of Uttarbasti on the uterine biophysical profile in unexplained infertility
 		 After each Uttarbasti cycle 
 
Secondary Outcome  
Outcome  TimePoints 
1. To investigate for the confirmation of unexplained infertility
2. To evaluate the changes in uterine biophysical profile through ultrasound.
 		 1. At screening
2. After each Uttarbasti cycle 
 
Target Sample Size   Total Sample Size="12"
Sample Size from India="12" 
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="1"
Months="0"
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  

This is a prospective, interventional, single-arm pilot clinical trial designed to evaluate the effect of Uttarbasti using Phala Ghrita on the uterine biophysical profile in women diagnosed with unexplained infertility. A total of 10 participants aged 20–40 years will be enrolled.

Each participant will undergo three cycles of Uttarbasti, administered under aseptic precautions. Ultrasound-based Uterine Biophysical Profile (including endometrial thickness, layering, vascularity, myometrial features, and Doppler indices) will be assessed at baseline and after each treatment cycle (between Day 12–16 of the menstrual cycle). Safety will be ensured through monitoring of vitals, adverse events, and procedural precautions.

The study aims to determine whether Uttarbasti improves parameters essential for implantation and fertility, thereby providing preliminary evidence on the therapeutic role of Uttarbasti in unexplained infertility.

 
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