FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/02/081320 [Registered on: 25/02/2025] Trial Registered Prospectively
Last Modified On: 22/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Effect Of Apamarga Kshar Taila Uttarbasti And Garbhaprada Yoga On Participants Who Have Vandhyatva Due To Tubal Block 
Scientific Title of Study   Clinical Study Of Apamarga Kshar Taila Uttarbasti And Garbhaprada Yoga In Vandhyatva (Tubal Blockage) 
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 POOJA KHANDAL 
Designation  M.S. Scholar 
Affiliation  Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University 
Address  PG Department of Prasuti Tantra evam Stree Roga, Post Graduate Institute of Ayurved Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University Nagaur Road Karwar Jodhpur RAJASTHAN 342037

Jodhpur
RAJASTHAN
342037
India 
Phone  7221855837  
Fax    
Email  poojakhandal13@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rashmi Sharma 
Designation  Associate Professor 
Affiliation  Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University 
Address  PG Department of Prasuti Tantra evam Stree Roga, Post Graduate Institute of Ayurved Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University Nagaur Road Karwar Jodhpur RAJASTHAN 342037

Jodhpur
RAJASTHAN
342037
India 
Phone  9166607559  
Fax    
Email  vd_rashmi11@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr POOJA KHANDAL 
Designation  M.S. Scholar 
Affiliation  Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University 
Address  PG Department of Prasuti Tantra evam Stree Roga, Post Graduate Institute of Ayurved Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University Nagaur Road Karwar Jodhpur RAJASTHAN 342037

Jodhpur
RAJASTHAN
342037
India 
Phone  7221855837  
Fax    
Email  poojakhandal13@gmail.com  
 
Source of Monetary or Material Support  
Post Graduate Institute of Ayurved Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University Nagaur Road Karwar Jodhpur RAJASTHAN 342037 
 
Primary Sponsor  
Name  Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University  
Address  PG Department of Prasuti Tantra evam Stree Roga, Post Graduate Institute of Ayurved Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University Nagaur Road Karwar Jodhpur RAJASTHAN 342037 
Type of Sponsor  Government medical college 
 
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 Pooja Khandal  Post Graduate Institute of Ayurved Jodhpur Rajasthan  PG Department of Prasuti Tantra evam Stree Roga, Post Graduate Institute of Ayurved Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University Nagaur Road Karwar Jodhpur RAJASTHAN 342037
Jodhpur
RAJASTHAN 		 7221855837

poojakhandal13@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Post Graduate Institute of Ayurveda Jodhpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N971||Female infertility of tubal origin. Ayurveda Condition: VANDHYA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Garbhaprada yoga, Reference: Chakradatt yonivyapadaadhikar 28, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Goghrita), Additional Information: Once in Day after cessation of menstrual flow for 20 days for 2 consecutive months.
2Intervention ArmProcedure-uttara-bastiH, उत्तर-बस्तिः (Procedure Reference: cha. si. 9/50, Procedure details: Apamarga Kshara Taila Intra Uterine Uttar Basti -5ml Once in a day From next day of cessation of menstrual flow for three days for 2 consecutive months.)
(1) Medicine Name: Apamarga Kshara Taila, Reference: 25 (Chakradatta Karnaroga Chikitsa- 57/25), Route: Vaginal, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Duration: 60 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Primary and secondary infertility as a result of Tubal blockage diagnosed by HSG.
Failure to conceive due to at least one tubal blockage within one or more years of regular unprotected coitus.
Age groups 18 to 40 years.

 
 
ExclusionCriteria 
Details  Patients are in the age group below 18 years and above 40 years.
Infertility is due to other factors like uterine factor, cervical factor, ovarian factor, and peritoneal factors.
Patients suffering from chronic diseases like Diabetes mellitus, Hypertension, Tuberculosis, Malignancy, Thyroid disorder, Severe anemia, etc.
Patients suffering from Hepatitis B, sexually transmitted diseases, and HIV.
Congenital anatomical defect of the female genital organ of the vulva & vagina
Contraindications of Uttar Basti.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Assessment of Interval of Menstrual cycle
2.Assessment of Duration of Menstruation.
3.Assessment of Dysmenorrhoea 		 60 Days 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of HSG
Assessment of blockage in tube
Assessment of Sites in Unilateral/Bilateral Tubal Blockage 		 60 Days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   02/04/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  02/04/2025 
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  

This is single group an exploratory study of Apamarga Kshar Taila Uttarbasti And Garbhaprada Yoga In Vandhyatva (Tubal Blockage). Female patients of child bearing age (18­-40 years) having Primary and secondary infertility as a result of Tubal blockage diagnosed by H.S.G. and Failure to conceive (due to atleast one tubal blockage) within one or more year of regular unprotected coitus and Patients having age group < 18 years and > 40 years, Infertility due to other factor like uterine factor, cervical factor, ovarian factor, peritoneal factor and Patient suffering from chronic diseases like Diabetes mellitus, Hypertension, Tuberculosis Malignancy, Thyroid disorder, Severe anaemia etc. and Patient suffering from Hepatitis B, sexually transmitted diseases, human immunodeficiency virus (HIV), Congenital anatomical defect of female genital organ of vulva & vagina and Contraindication of Uttar Basti (like Genital tract infection, heavy bleeding, etc. are excluded. Apamarga Kshara Taila Intra Uterine Uttar Basti -5ml Once in a day From next day of cessation of menstrual flow for three days for 2 consecutive months.. Garbhaprada Yoga Churna-3gm Orally Anupan – Goghrita Once in Day after cessation of menstrual flow for 20 days for 2 consecutive months.

 
Close