FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/07/055508 [Registered on: 21/07/2023] Trial Registered Prospectively
Last Modified On: 19/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Effect of Aamradi Hima and Shatavari Taila Matra basti on asrigdara 
Scientific Title of Study   CLINICAL STUDY OF AAMRADI HIMA AND SHATAVARI TAILA MATRA BASTI ON ASRIGDARA  
Trial Acronym  CSASB 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jyoti Kanwar Solanki 
Designation  P.G. Scholar 
Affiliation  Post Graduate Institute of Ayurveda,Dr.S R Rajasthan Ayurveda University,Jodhpur,Rajastha 
Address  P.G Department of Prasuti Tantra Evam Stri Roga Post Graduate Institute of Ayurveda Dr.S R Rajasthan Ayurveda University,karwad, Jodhpur,Rajasthan

Jodhpur
RAJASTHAN
342037
India 
Phone  8118817782  
Fax    
Email  jyotikanwarsolanki123456@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrANeelima 
Designation  Professor & HOD 
Affiliation  Post Graduate Institute of Ayurveda,Dr.S R Rajasthan Ayurveda University,Jodhpur,Rajasthan 
Address  P.G Department of Prasuti Tantra Evam Stri Roga Post Graduate Institute of Ayurveda Dr.S R Rajasthan Ayurveda University,karwad, Jodhpur Rajasthan

Jodhpur
RAJASTHAN
342037
India 
Phone  9610350131  
Fax    
Email  aspneelima@gmail.com  
 
Details of Contact Person
Public Query  
Name  Jyoti Kanwar Solanki 
Designation  P.G. Scholar 
Affiliation  Post Graduate Institute of Ayurveda,Dr.S R Rajasthan Ayurveda University,Jodhpur,Rajasthan 
Address  P.G Department of Prasuti Tantra Evam Stri Roga Post Graduate Institute of Ayurveda Dr.S R Rajasthan Ayurveda University,karwad, Jodhpur Rajasthan

Jodhpur
RAJASTHAN
342037
India 
Phone  8118817782  
Fax    
Email  jyotikanwarsolanki123456@gmail.com  
 
Source of Monetary or Material Support  
Post Graduate Institute of Ayurveda ,Jodhpur Rajasthan  
 
Primary Sponsor  
Name  Post Graduate Institute of Ayurveda ,Jodhpur Rajasthan 
Address  Post Graduate Institute of Ayurveda ,Dr.Sarvapalli Radha Krishnan Rajasthan Ayurveda University,Nagaur Road ,Karwad,Jodhpur ,Rajasthan,342037,India 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
DrJyoti Kanwar Solanki  Post Graduate Institute of Ayurveda ,Dr.Sarvapalli Radha Krishnan Rajasthan Ayurveda University,Nagaur Road ,Karwad,Jodhpur ,Rajasthan,342037,India 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrJyoti kanwar solanki  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, Nagaur Road, Karwad, Jodhpur, Rajasthan 342037 India Jodhpur RAJASTHAN
Jodhpur
RAJASTHAN 		 8118817782

jyotikanwarsolanki123456@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  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N921||Excessive and frequent menstruation with irregular cycle. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Aamradi Hima , Reference: (Sharangdhara Samhita/Madhyam khand /4/2), Route: Oral, Dosage Form: Sheeta/ Hima, Dose: 90(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: -
2Intervention ArmProcedure-mAtrAbastiH, मात्राबस्तिः (Procedure Reference: Charak samhita .siddhi sthan 4/52, Procedure details: Shatavari taila will be made by the reference of Sneha Kalpana in Sharangdhar Samhita madhyama khanda. Shatavari will be taken in the dry form and made kalka(paste) of it.then 1 part of kalka dravya and 4 parts of til taila and 16 parts of water will be mixed and it will be heated till only Sneha (oil)remains. )
(1) Medicine Name: Shatavari Taila, Reference: Sharadhara samhita /madhyam khand 9 , Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 14 Days
 
Inclusion Criteria  
Age From  14.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  Excessive bleeding or prolonged bleeding (More than 7 days) or shortness of cycle (<21 days).
⮚Excessive menstrual bleeding during menstruation (menstrual blood loss >80 ml in 1-7 days) having pictorial blood loss assessment chart (PBLAC) score more than 100 points for 2 consecutive cycles.
Along with or without Body ache (Angamarda) and Pain (Vedana)
Women between the age group 14 to 50 years (married & unmarried).
After 3 months withdrawal of OC pills.
 
 
ExclusionCriteria 
Details  Patients having bleeding due to abortion.
Bleeding from the site other than the uterus.
Patients with known Coagulation disorders.
Patients suffering from malignancies and chronic systemic diseases like, uncontrolled diabetes (above the range of 160-200 mg/dl), uncontrolled hypertension (Systolic blood pressure >180 & diastolic blood pressure >120mm hg).
Patients having Hepatitis, VDRL, HIV/AIDS.
If a patient conceives during trial.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Assess improvement of sign & symptoms according to Pictorial blood loss assessment chart   60 days 
 
Secondary Outcome  
Outcome  TimePoints 
Relief in associate symptoms like pain during menses,intermenstrual bleeding   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)   01/08/2023 
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   This is a single group ,open label  clinical study  to evaluate the effect of Amradi hima and shatavari taila matra basti in the management of Asrigdara .To reduce the sign and symptoms assess from the pictorial blood loss assessment chart(Amount and Duration of bleeding),intermenstrual bleeding with or without pain  and improve the amount of  hemoglobin .Aamradi hima was sheet,vata -pitta shamak,rakta stambhak ,Daha prashmak in nature and shatavari roots are  phytoestrogens. menorrhagia is due to an excess of estrogen or reduced estrogen (atrophy of endometrium) it can help in either case.The roots are considered as an astringent hence they reduce menstrual flow by this property. Moreover, Asparagus was found to be an effective antiulcerogenic and anti-secretory agent and thus has its role in healing of endometrium. Basti pacifying vata, restoring the disturbed Kapha and Pitta at their origin seats thus helps in breaking pathogenesis. so we are choosing matra basti in the management of Asrigdara. 
Close