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CTRI Number  CTRI/2024/04/065865 [Registered on: 16/04/2024] Trial Registered Prospectively
Last Modified On: 14/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A comparative clinical study to determine effect of rasona taila matrabasti and tila taila matrabasti in the management of kashtartava. 
Scientific Title of Study   A randomised parallel arm comparative clinical study to evaluate the efficacy of rasona taila matrabasti and tila taila matrabasti in the management of kashtartava. 
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 Prerna Jain 
Designation  PG scholar 
Affiliation  Seth Govindji Raoji Ayurved Mahavidyalaya Solapur 
Address  OPD no 4, Prasuti Tantra evum Streerog department, Seth Sakharam Nemchand Jain Ayurveda Rugnalaya, 118/119 shukrawar peth, near juni faujdar chawdi,solapur

Solapur
MAHARASHTRA
413002
India 
Phone  9823798487  
Fax    
Email  prerna.jain@pg.sgrayurved.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Veena Jawale 
Designation  HOD, Prasuti Tantra evum Streerog department 
Affiliation  Seth Govindji Raoji Ayurved Mahavidyalaya Solapur 
Address  OPD no 4, Seth Sakharam Nemchand Jain Ayurveda Rugnalaya, 118/119 shukrawar peth, near juni faujdar chawdi, solapur, MAHARASHTRA

Solapur
MAHARASHTRA
413002
India 
Phone  9028244410  
Fax    
Email  veena.jawale@sgrayurved.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Prerna Jain  
Designation  PG Scholar 
Affiliation  Seth Govindji Raoji Ayurved Mahavidyalaya Solapur 
Address  OPD no 4, Prasuti Tantra evum Streerog department, Seth Sakharam Nemchand Jain Ayurveda Rugnalaya, 118/119 shukrawar peth, near juni faujdar chawdi, solapur

Solapur
MAHARASHTRA
413002
India 
Phone  9823798487  
Fax    
Email  prerna.jain@pg.sgrayurved.edu.in  
 
Source of Monetary or Material Support  
Seth Sakharam Nemchand Jain Ayurveda Rugnalaya, 118/119 shukrawar peth, near juni faujdar chawdi, solapur, MAHARASHTRA 413002 India 
 
Primary Sponsor  
Name  Dr.Prerna Jain 
Address  Seth Sakharam Nemchand Jain Ayurveda Rugnalaya, 118/119 shukrawar peth, near juni faujdar chawdi, solapur, MAHARASHTRA 413002 India 
Type of Sponsor  Other [Self] 
 
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 Prerna Jain  Seth Sakharam Nemchand Jain Ayurveda Rugnalaya Solapur   OPD NO 4, Prasuti Tantra evum Streerog department, Seth Sakharam Nemchand Jain Ayurveda Rugnalaya, 118/119 shukrawar peth, near juni faujdar chawdi, solapur, MAHARASHTRA 413002 India
Solapur
MAHARASHTRA 		 9823798487

prerna.jain@pg.sgrayurved.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Seth Sakharam Nemchand Jain Ayurveda Rugnalaya Solapur.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N944||Primary dysmenorrhea. Ayurveda Condition: ARTAVADOSHAH/ARTAVADUSHTIH/RAJODOSHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-mAtrAbastiH, मात्राबस्तिः (Procedure Reference: charak siddhisthana, Procedure details: 8 consecutive days before expected date of menstruation (For 3 consecutive cycles) )
(1) Medicine Name: rasona taila, Reference: kashyapa samhita kalpasthana 2/93-96, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 24 Days
2Comparator ArmProcedure-mAtrAbastiH, मात्राबस्तिः (Procedure Reference: charak samhita siddhisthana, Procedure details: 8 consecutive days before expected date of menstruation (For 3 consecutive cycles) )
(1) Medicine Name: tila taila, Reference: charak sutrasthana 13/15, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 24 Days
 
Inclusion Criteria  
Age From  13.00 Year(s)
Age To  25.00 Year(s)
Gender  Female 
Details  1. Irrespective of marital status of age 13-25 years.
2. Participant with regular menstrual cycle.
3. Participant with painful menses for at least 2 consecutive menstrual cycles. 
 
ExclusionCriteria 
Details  1. Congenital anomalies of uterus or ovaries which affects her menstruation.
2. Participant with any uterine pathology (fibroid, cervical polyp, adenomyosis, etc).
3. Participant on hormonal therapy (oral contraceptive) or using an IUCD, PCOS, Anaemia.
4. Participant having Parikartika, Arsha.
5. Participant with known case of Diabetes Mellitus, Hypertension, Hypothyroid. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of Rasona Taila Matra Basti in Kashtartava.  8 consecutive days before expected date of menstruation (For 3 consecutive cycles) 
 
Secondary Outcome  
Outcome  TimePoints 
To Study the safety of Rasona & Tila Taila Matrabasti in the management of Kashtartava  3 months 
To evaluate the efficacy of Til taila matrabasti in Kashtartava  8 consecutive days before expected date of menstruation (For 3 consecutive cycles) 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   N/A 
Date of First Enrollment (India)   26/04/2024 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   In Ayurvedic classics, all gynaecological problems are described under the broad tittle of Yonivyapada, Though the disease, Kashtartava is not explained as a separate disease, it is described as symptom as anciently females were not suffering much from this problem due to Rutucharya and Rajaswalacharya. It is a symptom of various Yonivyapadas specially Udavartini Yonivyapad, Vatala Yonivyapad and Sannipatiki Yonivyapada. On the basis of signs and symptoms, it can be compared with Dysmenorrhoea, which is not associated with any identifiable pelvic pathology. Dysmenorrhoea or pain during menstruation is probably the most frequent of all symptoms seen in gynaecological disorders, it can be explained as a cramping pain accompanying menstruation. Genetic factors, exertion and activity patterns affect prevalence and severity of dysmenorrhoea. Various studies in India revealed that the prevalence of dysmenorrhoea varies from 33 to 79.67%. However, the true incidence and prevalence of dysmenorrhoea are not clearly established in India and also exact characteristics are also not clearly known. Hence this topic is selected to compare the efficacy of Rasona Taila Matrabasti and Tila Taila Matrabasti in Kashtartava. The study will be conducted for 3 conservative menstrual cycle. There will be follow up on every 5th day of 1st, 2nd and 3rd menstrual cycle. 
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