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CTRI Number  CTRI/2023/02/049910 [Registered on: 20/02/2023] Trial Registered Prospectively
Last Modified On: 20/02/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A randomized clinical study to evaluate the effect of Kashmaryadi ghrita orally and as enema along with pushpadhanwa rasa in female infertility .  
Scientific Title of Study   A randomised comparative clinical study to evaluate the effect of Kashmaryadi ghrita orally and as matra basti along with pushpadhanwa rasa in Vandyatwa With special reference to female 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 KAVYA BN  
Designation  PG SCHOLAR  
Affiliation  SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA UDUPI  
Address  Department of prasuthi tantra and stri roga , Shri Dharmasthala Manjunatheshwara college of Ayurveda udupi
Department of prasuthi tantra and stri roga , Shri Dharmasthala Manjunatheshwara college of Ayurveda udupi
Udupi
KARNATAKA
574118
India 
Phone  9108246604  
Fax    
Email  kavyanaik381@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR MAMATHA KV 
Designation  PRINCIPAL AND PROFESSOR  
Affiliation  SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA UDUPI  
Address  PRINCIPAL , PROFESSOR DEPARTMENT OF PRASUTHI TANTRA AND STRI ROGA SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA UDUPI

Udupi
KARNATAKA
574118
India 
Phone  9108246604  
Fax    
Email  mamath2@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR MAMATHA KV  
Designation  PRINCIPAL , PROFESSOR  
Affiliation  SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA UDUPI  
Address  Principal , Professor Department of prasuthi tantra and stri roga , Shri Dharmasthala Manjunatheshwara college of Ayurveda udupi

Udupi
KARNATAKA
574118
India 
Phone  9448215605  
Fax    
Email  mamath2@gmail.com  
 
Source of Monetary or Material Support  
SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA KUTHPADY UDUPI KARNATAKA 574118 
 
Primary Sponsor  
Name  SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA KUTHPADY UDUPI KARNATAKA . 
Address  SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA KUTHPADY UDUPI KARNATAKA . 
Type of Sponsor  Private 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 KAVYA BN  SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA KUTHPADY UDUPI KARNATAKA .  DEPARTMENT OF PG STUDIES IN PRASUTHI TANTRA AND STRI ROGA UDUPI KARNATAKA
Udupi
KARNATAKA 		 9108246604

kavyanaik381@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE SRI DHARMASTHALA MANJUNATHESWARA COLLEGE OF AYURVEDA AND HOSPITAL UDUPI   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,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: KASHMARYADI GHRITHA , Reference: CHARAKA SAMHITHA 30TH CHAPTER, Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -MILK ), Additional Information: -
2Comparator ArmProcedure-mAtrAbastiH, मात्राबस्तिः (Procedure Reference: charaka samhitha 30th chapter , Procedure details: 60ml of kashmaryadi ghritha is given for 7 days after cessatio of menstruation for two consecutive cycles . )
(1) Medicine Name: Kahmaryadi ghritha , Reference: charaka samhitha 30th chapter , Route: Rectal, Dosage Form: Ghrita, Dose: 60(ml), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  MARRIED FEMALES AGED BETWEEN 19-40 YEARS
PATIENT WITH ACTIVE MARITAL LIFE
PATIENT FULFILLING DIAGNOSIT CRITERIA
INFERTILITY DUE TO ANOVULATION
INFERTILITY DUE TO ENDOMETRIAL FACTOR
PATIENT HAVING INTRAMURAL AND SUBSEROSAL FIBROID UTERUS
PATIENT WITH PARTNERS HAVING NORMAL SEMENOGRAM  
 
ExclusionCriteria 
Details  UTERUS WITH CONGENITAL ANOMALIES
PATIENT WITH ACTIVE PELVIC INFECTION
PATIENT WITH SUBMUCOSAL UTERINE FIBROIDS
PATIENT PRESENTING WITH DYSFUNCTIONAL UTERINE BLEEDING
PATIENTS SUFFERING FROM GENITAL TUBERCULOSIS
PATIENTS WITH HYDROSALPHINX AND TUBAL BLOCK
ANY OTHER SYSTEMIC ILLNESS SUCH AS DM, HTN, THYROID DYSFUNCTION TUBERCULOSIS ETC.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
CONCEPTION EVIDENCED BY UPT AND USG
 		 CONCEPTION EVIDENCED BY UPT AND USG
CONCEIVED
NOT CONCEIVED
CHANGE IN SIZE AND NUMBER OF FOLLICLES (AFC)AND OVULATION BY FOLLICULAR STUDY AFTER 8 WWEEKS
CHANGE IN ENDOMETRIAL THICKNESS EVIDENCED BY USG AFTER 8 WEEKS OF STUDY  
 
Secondary Outcome  
Outcome  TimePoints 
1)CONCEPTION
2)Ovulation evidenced by follicular study
3) Attainement of shuddha arthava lakshana
 		 1)3 MONTHS
2) 2 months
3) 3 months  
 
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)   20/02/2023 
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   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

ACCORDING TO WHO INFERTILITY IS A DISEASE OF THE REPRODUCTIVE SYSTEM DEFINED BY THE FAILURE TO ACHIEVE A CLINICAL PREGNANCY AFTER 12 MONTHS OR MORE OF REGULAR UNPROTECTED SEXUAL INTERCOURSE.

A ROUGH ESTIMATE SUGGESTS THAT MORE THAN 20 MILLION COUPLES IN INDIA SUFFER FROM INFERTILITY. CURRENTLY THE INFERTILITY RATE AMONG THE INDIAN POPULATION IS 10 TO 14 % WHICH IS HIGHER IN URBAN AREAS WHERE 1 OUT OF 6 COUPLES ARE AFFECTED. THE CAUSE OF INFERTILITY IN FEMALE CAN BE DUE TO VARIOUS CAUSES LIKE OVULATORY DYSFUNCTION, TUBAL FACTOR, ENDOMETRIAL FACTOR, CERVICAL FACTOR, PELVIC INFLAMMATORY DISEASE, IMMUNOLOGICAL FACTOR, SYSTEMIC CONDITIONS, COITAL ERROR, UNEXPLAINED INFERTILITY ETC.

VATA PLAYS AN IMPORTANT ROLE IN GARBHADHARANA. IMBALANCE IN APANAVATA IS ONE OF THE MAJOR CAUSE OF VANDYATWA, VANDYATWA IS ONE AMONG THE 80 VATAJA NANTMAJA VIKARAS. NORMALIZATION OF VATADOSHA IS THE PRIMARY MANAGEMENT IN VANDYATWA. BASTI IS SAID TO BE PARAMAUSHADHI FOR TREATING VATAJA ROGA. ANUVASANA BASTI IS HIGHLY BENEFICIAL FOR WOMAN THOSE WHO ARE INFERTILE.

 KASHMARYADI GHRITA MENTIONED IN YONIVYAPAT CHIKITSA OF CHARAKA SAMHITA HAS THE EFFICACY OF GARBHADA AND YONI VATAHARA PROPERTIES.PUSHPADHANWA RASA AS MENTIONED IN VAJIKARANA ADHYAYA OF BHAISHAJYA RATNAVALI AND RASATARANGINI PARISHISHTA IS FOUND BENEFICIAL IN VANDYATWA AND ALSO THE DRUGS USED IN THE PUSHPADHANWA RASA HAS VATAHARA, DEEPANA PACHANA PROPERTIES AND IT IS BALYA AND GIVES DHIRGA AYU AND IT HAS VAJIKARANA PROPERTIES. ANUVASANA BASTI IS SHRESTHA CHIKITSA FOR WOMEN THOSE WHO ARE INFERTILE. .

 
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