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CTRI Number  CTRI/2024/06/069357 [Registered on: 21/06/2024] Trial Registered Prospectively
Last Modified On: 19/06/2024
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 add on effect of two drugs, Pippalyadi Churna with Lodhradi Yonivarti in the management of kaphaj Yonivyapad with special reference to Vaginitis. 
Scientific Title of Study   A randomized controlled trial of add on effect of Pippalyadi Churna with Lodhradi Yonivarti in the management of Kaphaj Yonivyapad with special reference to Vaginitis. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ashwini Ramchandra Metangale 
Designation  PhD Scholar 
Affiliation  Government Ayurved College Nagpur 
Address  Government Ayurved College Department of Prasutitantra Streerog, Second floor Raje Raghuji Nagar Umred Road Sakkardara Chowk Nagpur

Nagpur
MAHARASHTRA
440024
India 
Phone  8805554999  
Fax    
Email  dr.ashwinibarai@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anita D Bomarde 
Designation  Professor & HOD PhD Guide 
Affiliation  Government Ayurved College Nagpur 
Address  Government Ayurved College Department of Prasutitantra Streerog, Second floor Raje Raghuji Nagar Umred Road Sakkardara Chowk Nagpur

Nagpur
MAHARASHTRA
440024
India 
Phone  9970115160  
Fax    
Email  dr.adbombarde67@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ashwini Ramchandra Metangale 
Designation  PhD Sholar 
Affiliation  Government Ayurved College Nagpur 
Address  Government Ayurved College Department of Prasutitantra Streerog, Second floor Raje Raghuji Nagar Umred Road Sakkardara Chowk Nagpur

Nagpur
MAHARASHTRA
440024
India 
Phone  8805554999  
Fax    
Email  dr.ashwinibarai@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurved College Nagpur 
 
Primary Sponsor  
Name  Ashwini Ramchandra Metangale 
Address  Government Ayurved college and Hospital Department of Prasutitantra Streerog, Second Floor Raje Raghuji Nagar Umred Road Sakkardara Chowk Nagpur - 440024 
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 Ashwini Metangale  Government Ayurved College and Hospital Nagpur  OPD No.42 Prasutitantra Streerog OPD,Raje Raghuji Nagar Umred Road Sakkardara Chowk, Nagpur 440024
Nagpur
MAHARASHTRA 		 8805554999

dr.ashwinibarai@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Government Ayurved College and Hospital Nagpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N761||Subacute and chronic vaginitis. Ayurveda Condition: KAPAJA-YONIROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-yoni varti, योनि वर्ति (Procedure Reference: Sharangdhar Samhita Madhyam Khand 7/1, Procedure details: Under all aseptic conditions finely powdered & sieved churna of Lodhra Priyangu Madhuk taken in equal quantity & mixed with appropriate amount of Honey as an adhesive agent to prepare Yonivarti.After voiding of urine Lithotomy position will be given to the patient. Yonisnehan & yoniprakshalan will be done with Til tail and Leukwarm water as a Purvakarma.Then under all aseptic precautions Lodhradi Yonivarti inserted in Yonimarg.)
(1) Medicine Name: Lodhradi Yonivarti, Reference: Charak Chikitsa 30/117-120, Route: Vaginal, Dosage Form: Varti/ Suppository, Dose: 3(g), Frequency: od, Duration: 7 Days
2Intervention ArmProcedure-yoni varti, योनि वर्ति (Procedure Reference: Sharangdhar samhita Madhyam Khand 7/1, Procedure details: Under all aseptic conditions finely powedered & sieved churna of Lodhra Priyangu Madhuk taken in equal quantity& mixed with appropriate amount of honey as an adhesive agent to prepare Yonivarti. After voiding of urine Lithotomy position will be given to the patient. Yonisnehan & Yoniprakshalan will be done with Til tail & leukwarm water as a purvakarma.Then under all aseptic precautions Lodhradi Yonivarti inserted in Yonimarg. )
(1) Medicine Name: Lodhradi Yonivarti, Reference: Charak Chikitsa 30/117-120, Route: Vaginal, Dosage Form: Varti/ Suppository, Dose: 3(g), Frequency: od, Duration: 7 Days
3Intervention ArmDrugClassical(1) Medicine Name: Pippalyadi Churna, Reference: Charak Chikitsa 30/84, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: -For Interventional arm Pippalyadi churna 5 gms orally and Lodhradi Yonivarti 3gms vaginally given combinely to study the add on effect of Pippalyadi churna with Lodhradi Yonivarti.
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  1. Patient within 18-50 years of age group
2. Only married patients willing to participate in the trial.
3. Patients having sign and symptoms of Kaphaj Yonivypad 
 
ExclusionCriteria 
Details  1. Unmarried patients
2. Pregnant women
3. Post menopausal women
4.STD
5.Patients on oral contraceptive pills and IUCD
6. Patients with major illness like HT, DM, TB etc
5. Any type of Malignancy 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Overall assessment of improvement by add on effect of Pippalyadi churna with Lodhradi Yonivarti in the management of Kaphaj Yonivyapad with percentage reduction in Amount of vaginal discharge, consistency,Smell, Vaginal Itching.  Day 0, day 7, Day 15, Day 30 
 
Secondary Outcome  
Outcome  TimePoints 
Evaluate the total improvement by Add on effect of Pippalyadi churna with Lodhradi Yonivarti in the symptoms of Kaphaj Yonivyapad i.e. Amount of vaginal discharge, Consistency, Smell, Vaginal itching by using objective criteria Vaginal culture & vaginal pH.  Before treatment i.e. 0th day & after treatment i.e. 30th day 
 
Target Sample Size   Total Sample Size="114"
Sample Size from India="114" 
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)   01/07/2024 
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="3"
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 randomised open labelled parallel group multicentre trial to study the add on effect of Pippalyadi churna 5gms orally and Lodhradi Yonivarti 3gms locally with Lodhradi Yonivarti alone in the patients of Kaphaj Yonivyapad . Trial will be conducted on two centres in India. Primary outcome measures will be relief in the syptoms of Kaphaj Yonivyapad on 30th day as per subjective criteria and secondary outcome measures will be relief in the symptoms of Kaphaj Yonivyapad on 7th and 15th day as per subjective criteria. 
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