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CTRI Number  CTRI/2023/07/055680 [Registered on: 25/07/2023] Trial Registered Prospectively
Last Modified On: 22/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Shatapushpa Tail Uttarbasti & Sharpunkha Ghan Vati in the treatment of Vandhyatva (Infertility due to Anovulation) 
Scientific Title of Study   Comparative Study of Shatapushpa Tail Uttarbasti & Sharpunkha Ghan Vati in the management of Vandhyatva (Anovulation) 
Trial Acronym  CSMV 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kanchan Choyal 
Designation  P.G. Scholar 
Affiliation  Post Graduate Institute of Ayurved Jodhpur, Rajasthan 
Address  P.G. Department of Prasuti Tantra Evam Stri Roga, Post Graduate Institute of Ayurved, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur, Rajasthan India

Jodhpur
RAJASTHAN
342037
India 
Phone  7734842989  
Fax    
Email  dr.kanchanchoudhary121@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rashmi Sharma 
Designation  Associate Professor 
Affiliation  Post Graduate Institute of Ayurved Jodhpur, Rajasthan 
Address  P.G. Department of Prasuti Tantra Evam Stri Roga, Post Graduate Institute of Ayurved, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur, Rajasthan India

Jodhpur
RAJASTHAN
342037
India 
Phone  9166607559  
Fax    
Email  vd_rashmi11@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Kanchan Choyal 
Designation  P.G. Scholar 
Affiliation  Post Graduate Institute of Ayurved Jodhpur, Rajasthan 
Address  P.G. Department of Prasuti Tantra Evam Stri Roga, Post Graduate Institute of Ayurved, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur, Rajasthan India

Jodhpur
RAJASTHAN
342037
India 
Phone  7734842989  
Fax    
Email  dr.kanchanchoudhary121@gmail.com  
 
Source of Monetary or Material Support  
Post Graduate Institute of Ayurved, Jodhpur, Rajasthan  
 
Primary Sponsor  
Name  Post Graduate Institute of Ayurved, Jodhpur, Rajasthan 
Address  P.G. Department of Prasuti Tantra Evam Stri Roga, Post Graduate Institute of Ayurved, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur, Rajasthan, INDIA 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Dr Kanchan Choyal  P.G. Department of Prasuti Tantra Evam Stri Roga, Post Graduate Institute of Ayurved, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur, Rajasthan, INDIA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kanchan Choyal  Post Graduate Institute of Ayurved ,Jodhpur, Rajasthan   P.G. Department of Prasuti Tantra Evam Stri Roga(OPD no. 5),Post Graduate Institute of Ayurved, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur, Rajasthan, INDIA
Jodhpur
RAJASTHAN 		 7734842989

dr.kanchanchoudhary121@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Post Graduate Institute of Ayurved Jodhpur, Rajasthan   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N970||Female infertility associated withanovulation. Ayurveda Condition: Female infertility,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Sharpunkha Ghan Vati, Reference: Ras Ratan Samuchaya 22/51-52, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Godugdh), Additional Information: -
2Comparator ArmProcedure- उत्तर-बस्ति (Procedure Reference: Kashyap Samhita /Shatapushpa Shatawari Kalp /5-17, Procedure details: Prior to administration of Uttarabasti, Kosthashodhana will be done in all patients by giving Erandabrushtaharitaki 5gm at bedtime with hot water. Just before the main procedure Snehan with Tila Taila for 10 min and Nadisweda will be performed for 5 min below umbilicus and both lower limbs. Later on after Yoni Prakshalana with Triphala Kwath, Shatapushpa Tail Uttarabasti in the dose of 5 ml intrauterine just above the internal os with IUI (Intra Uterine Insemination) cannula will be given. A)
(1) Medicine Name: Shatapushpa Tail, Reference: Kashyap Samhita /Shatapushpa Shatawari Kalp /5-17, Route: Vaginal, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Duration: 2 Months
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1. Patient having complaint of failure to conceive (due to Anovulation) within one or more year of regular unprotected coitus. 2. Age groups-18 to 40 years 3.Primary or secondary infertility with Anovulatory factors. 
 
ExclusionCriteria 
Details  1.Infertility due to other factor like uterine factor, cervical factor, tubal factor, peritoneal factor.
2.Infertility due to abnormality in male partner.
3.Patient suffering from chronic diseases like Hypertension, Diabetes mellitus, Malignancy, Thyroid disorder, Severe anaemia, Tuberculosis etc.
4.Patient suffering from Hepatitis B, sexually transmitted diseases, human immunodeficiency virus (HIV).
5.Congenital anatomical defect of female genital organ
6.Surgical factors like Ovarian tumour, Ovarian endometrioma, etc.
7.Contraindication of Uttar Basti (like Genital tract infection, heavy bleeding, etc.) 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in Dominant follicle size & Endometrial thickness.  Improvement in Dominant follicle size & Endometrial thickness. 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in Interval of menstrual cycle, Duration of Bleeding, Dyspareunia  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)   01/09/2023 
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  
In randomised comparative clinical trial on 30 diagnosed vandhyatva (female Infertility) w.s.r. Anovulatory factor. Female Patients of child Bearing age (18-40yrs) having active married life minimum 1 year
and suffering from Infertility with at least 2 or more consecutive anovulatory cycles were included. Female Patients having age less than 18years and more than 40years and Congenital deformities , infectious
diseases of reproductive tract like tuberculosis, Sexually transmitted  diseases and carcinoma, DM, HIV, HTN were excluded. Group A patients were given with Sharpunkha Ghan Vati in a dose of 500 mg tds for 7 days for 2 month. Group B patients were given with Shatapushpa Tail Uttaarbasti 5 ml for 2 consecutive cycles.

Conclusion: In Nut cell, it can be concluded that Shatapushpa tail Uttarbasti is more effective compared to Sharpunkha Ghan Vati. Final conclusion of the study will be arrived at only after completion of the study.
 
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