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CTRI Number  CTRI/2022/03/040864 [Registered on: 07/03/2022] Trial Registered Prospectively
Last Modified On: 25/02/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Ayurvedic management of female infertility  
Scientific Title of Study   Efficacy of Lashunadi Taila Matrabasti along with Shatapushpa Choorna orally in the management of Vandhyatva ( Female infertility) w.s.r to anovulatory factor in Sthoulya: An open labeled single arm clinical 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ASWANI GS 
Designation  MS Scholar 
Affiliation  ITRA Jamnagar 
Address  Department of Prasuti tantra and Stree roga, 5th floor, Institute main building, ITRA Jamnagar, Gujarat Ayurveda University, Opp Reliance Smart,

Jamnagar
GUJARAT
361008
India 
Phone  9605932933  
Fax    
Email  aswanigv@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Shilpa B Donga 
Designation  Associate Professor  
Affiliation  ITRA Jamnagar 
Address  Department of Prasuti tantra and Stree roga, 5th floor, Institute main building, ITRA Jamnagar, Gujarat Ayurveda University, Opp Reliance Smart,

Jamnagar
GUJARAT
361008
India 
Phone  9825646796  
Fax    
Email  drshilpadonga@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Prof Shilpa B Donga 
Designation  Associate Professor  
Affiliation  ITRA Jamnagar 
Address  Department of Prasuti tantra and Stree roga, 5th floor, Institute main building, ITRA Jamnagar, Gujarat Ayurveda University, Opp Reliance Smart,

Junagadh
GUJARAT
361008
India 
Phone  9825646796  
Fax    
Email  drshilpadonga@yahoo.com  
 
Source of Monetary or Material Support  
Institute of Teaching and Research in Ayurveda, Jamnagar, Opp. Reliance smart, Jamnagar, Gujarat- 361008 
 
Primary Sponsor  
Name  Director ITRA Jamnagar 
Address  ITRA Jamnagar 
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 
Aswani GS  ITRA Jamnagar  IPD Ward Department of Prasuti and Stree roga, 1st floor, ITRA Jamnagar
Jamnagar
GUJARAT 		 9605932933

aswanigv@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE FOR ITRA JAMNAGAR 361008 PGT/7/A/Ethics/2021-22/1430(29)  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: VANDHYA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-mAtrAbastiH, मात्राबस्तिः (Procedure Reference: Kashyapa samhita, Procedure details: After poorva karma patient will be advised to lie downn in left lateral position, the catheter will be gently inserted into the anal canal and enema syringe containing 60 ml of Lashunaditaila will be administered with uniform pressure at morning after light diet)
(1) Medicine Name: Shatapushpa choorna, Reference: Kashyapa samhitha, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Duration: 2 Months
(2) Medicine Name: Lashunadi taila, Reference: kashyapa samhitha, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 14 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Female Patients of reproductive age ≥ 20 and ≤40 years
Patients having overweight (BMI 25-29 Kg/M2 ) or obese (BMI >30 Kg/M2)
Patients who have completed active married life of minimum1-year duration and suffering from Infertility with 2 or more consecutive anovulatory cycles.
Both Primary and secondary infertile patients having anovulatory cycle or with immature ovarian follicle.
Patient eligible& willing for Basti
Patients willing to participate in trial
 
 
ExclusionCriteria 
Details  Female Patients having age < 20years and >40years.
Patient with infectious diseases of reproductive tract like tuberculosis, sexually transmitted diseases
Organic lesions of reproductive tract like tuberculosis, carcinoma and congenital deformities.
Patients with history of cardiac diseases, Uncontrolled Diabetes (above 200 mg/dl- RBS) & Hypertension (Systolic BP above 160 & Diastolic above 100mmhg), TB, etc.
Patient with Hepatitis C, Hepatitis B
Patient not eligible for Basti
Pitta dominant Prakruti patients
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
It is expected that the trial drugs will induce the ovulation.  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Trail drugs will cure menstrual abnormalities associated with anovulation like irregular, scanty menstruation, dysmenorrhoea
It is expected that drugs will help to reduce BMI of patient.

 		 3 months 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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 3 
Date of First Enrollment (India)   01/04/2022 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not published yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

This is an open labelled single arm clinical trial to study the efficacy of Lashunadi taila matrabasti along with Satapushpa choorna orally in the management of female infertility with special reference to anovulation factor in sthoulya. 20 Diagnosed female infertile patients with overweight (BMI >25 kg/m2) or obesity (BMI > 30 kg/m2)  between age group of 20 year – 40 year based USG parameters (anovulatory cycle), fulfilling the selection criteria will be selected & given Matrabasti of Lashunadi Taila  for 2months (2 consecutive menstrual cycle, after the cessation of menses daily for 7days) along with Shatapushpa Choorna orally for 2 months. Shatapushpa Choorna will be given orally 5gm in empty stomach (Morning & evening with Goghrita).Lashunadi Taila Matrabasti will be given through rectal route (60ml) at morning 8:30 to 10:30 after light diet. The follow up period will be one month.

 
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