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CTRI Number  CTRI/2024/04/065514 [Registered on: 10/04/2024] Trial Registered Prospectively
Last Modified On: 12/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Therapeutic]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Clinical Trial to study the effects of two drugs, Tuttha Pratisaran and Kushthadi Varti in married women of reproductive age group having Cervical Erosion. 
Scientific Title of Study   Effect of Tuttha Pratisaran and Kushthadi Varti in management of Cervical Erosion in married women of reproductive age group: A Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Arpita Maulik Shah 
Designation  PhD Scholar 
Affiliation  Government Ayurved College, Nagpur 
Address  Government Ayurved College, Department of Prasutitantra Streerog, 2nd Floor, Raje Raghuji Nagar, Umred Road,Sakkardara Chowk, Nagpur -440024
Raje Raghuji Nagar, Umred Road,Sakkardara Chowk, Nagpur -440024
Nagpur
MAHARASHTRA
440024
India 
Phone  9890201302  
Fax    
Email  arpita1801@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Manoj V Gaikwad 
Designation  Professor & HOD ( PhD Guide) 
Affiliation  RA Podar Ayurved Medical College and Hospital, 
Address  RA Podar Ayurved Medical College , Dept of Prasutitantra & Streeroga, Annie Besant Road, Worli, Mumbai-
RA Podar Ayurved Medical College and Hospital, Annie Besant Road, Worli, Mumbai-400018
Mumbai
MAHARASHTRA
400018
India 
Phone  9822752816  
Fax    
Email  drmanojvgaikwad@gmail.com  
 
Details of Contact Person
Public Query  
Name  Arpita Maulik Shah 
Designation  PhD Scholar 
Affiliation  Government Ayurved College, Nagpur 
Address  Government Ayurved College, Department of Prasutitantra and Streerog, 2nd Floor, Raje Raghuji Nagar, Umred Road,Sakkardara Chowk, Nagpur -440024
Raje Raghuji Nagar, Umred Road,Sakkardara Chowk, Nagpur -440024
Nagpur
MAHARASHTRA
440024
India 
Phone  9890201302  
Fax    
Email  arpita1801@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurved College, Raje Raghuji Nagar, Umred Road, Nagpur 440024  
 
Primary Sponsor  
Name  Dr Arpita Maulik Shah 
Address  Government Ayurved College and Hospital, Department of Prasutitantra and Streerog, 2nd Floor, Raje Raghuji Nagar, Umred Road, Nagpur-440 024 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Bhausaheb Mulak Ayurved Mahavidyalaya Nandanvan Nagpur  KDK Campus, Great Nag Road, NAndanvan, Nagpur- 440009 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Arpita Maulik Shah  Bhausaheb Mulak Ayurved Mahavidyalaya  OPD No. 5, Prasutitantra Streerog OPD, Bhausaheb Mulak Ayurved Mahavidyalaya, KDK Campus, Great Nag Road, Nandanvan, Nagpur 440009
Nagpur
MAHARASHTRA 		 9890201302

arpita1801@gmail.com 
Dr Arpita Maulik Shah  Government Ayurved College  OPD No. 42, Streerog- Prasutitantra OPD, Government Ayurved College, Raje Raghuji Nagar, Umred Road,Sakkardara Chowk, Nagpur -440024
Nagpur
MAHARASHTRA 		 9890201302

arpita1801@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
IEC, BMAM, Nandanvan, Nagpur  Approved 
IEC, Government Ayurved College, Nagpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N86||Erosion and ectropion of cervix uteri. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-pratisAraNam, प्रतिसारणम् (Procedure Reference: Sushrut Vrana Chikitsa, Procedure details: Tuttha Pratisaran Under aseptic precautions TUTTHA will be applied on erosion site with the help of gauze piece and artery forceps till the count of 100(Vakshatam). 250 mg to 1 gm (according to area of erosion) For 7 days after cessation of menses )
(1) Medicine Name: Tuttha, Reference: API, Volume 1, Pg83, Route: Vaginal, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: od, Duration: 7 Days
2Comparator ArmProcedure-vartiH, वर्तिः (Procedure Reference: Charak Yonivyapad Chikitsa, Procedure details: Kushthadi Varti Under aseptic precautions KUSHTHADI VARTI will be inserted vaginally near erosion site for 1 muhurt (48 minutes). 1 Varti inserted vaginally once in a day For 7 days after cessation of menses )
(1) Medicine Name: Kushthadi Varti, Reference: Charak Yonivyapad Chikitsa, Route: Vaginal, Dosage Form: Varti/ Suppository, Dose: 1(NA), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1.Patients having signs and symptoms who fulfill the diagnostic criteria for Cervical Erosion.
2.Patient willing to give consent for the study. 
 
ExclusionCriteria 
Details  1. Cervical or Uterine Malignancy.
2. Pregnant patient.
3. Systemic Diseases like Diabetes Mellitus.
4. Infections like HIV, VDRL, STD, HPV.
5. Cervical polyp.
6. Puerperium
7. Patient unwilling to give consent.

 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of Tuttha Pratisaran and Kushthadi Varti in the management of cervical erosion with percentage reduction in size of cervical Erosion.
 		 Day 0, Day 7, Day 30

 
 
Secondary Outcome  
Outcome  TimePoints 
Effect of Tuttha Pratisaran on overall improvement in the healing of cervical erosion by objective criteria, Vaginal pH and Pap Smear Examination.
 		 Secondary End points -
Effect of Tuttha Pratisaran on overall improvement in the healing of cervical erosion by objective criteria, Vaginal pH and Pap Smear Examination before treatment(day 0) and after treatment(day 30)
 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   30/04/2024 
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="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 study is a randomized, parallel group, open labelled, controlled clinical trial to evaluate the effectiveness of TUTTHA PRATISARAN 1gm daily on erosion site with KUSHTHADI VARTI administered once daily vaginally for 7 days in patients of age 18 - 45 years having cervical erosion. The primary outcome measures will be relief from the symptoms of cervical erosion like Vaginal discharge, odour, pruritis, backache, lower abdominal pain, burning micturation and cervical tenderness before and after treatment on day 30. The secondary outcome measures will be overall improvement in the healing of cervical erosion by examination of Vaginal pH and PAP Smear before and after treatment on day 30. The results obtained will be analysed statistically to draw conclusions from the study. 
 
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