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CTRI Number  CTRI/2024/07/071566 [Registered on: 30/07/2024] Trial Registered Prospectively
Last Modified On: 14/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Clinical Trial to Study the Effect Of Sharapunkha Madhu Pratisaran in Garbhashay Grivagat Vrana with Special Reference to Cervical Ectopy. 
Scientific Title of Study   A Randomized Controlled Clinical Trial to Study the Effect Of Sharapunkha Madhu Pratisaran in Garbhashay Grivagat Vrana with Special Reference to Cervical Ectopy. 
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 Vaishnavi Adinath Kale  
Designation  PG student 
Affiliation  SMBT Ayurved College and Hospital 
Address  Department of Prasuti tantra avum Streeroga SMBT Ayurved College and Hospital Dhamangaon Nashik-42203

Nashik
MAHARASHTRA
422403
India 
Phone  08275543077  
Fax    
Email  vakale96@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pradnya Prataprao Deshmukh 
Designation  HOD and Professor 
Affiliation  SMBT Ayurved College and Hospital 
Address  Department of Prasuti tantra avum Streeroga SMBT Ayurved College and Hospital Dhamangaon Nashik-42203

Nashik
MAHARASHTRA
422403
India 
Phone  9766310638  
Fax    
Email  drpradnya2013@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vaishnavi Adinath Kale  
Designation  PG student 
Affiliation  SMBT Ayurved College and Hospital 
Address  Department of Prasuti tantra avum Streeroga SMBT Ayurved College and Hospital Dhamangaon Nashik-42203

Nashik
MAHARASHTRA
422403
India 
Phone  08275543077  
Fax    
Email  vakale96@gmail.com  
 
Source of Monetary or Material Support  
Department of Prasuti tantra avum Streeroga SMBT Ayurved College and Hospital Dhamangaon Nashik 
 
Primary Sponsor  
Name  Dr Vaishnavi Adinath Kale  
Address  Department of Prasuti tantra avum Streeroga SMBT Ayurved College and Hospital Dhamangaon Nashik-422403 
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 Vaishnavi Adinath Kale   SMBT Ayurved College and Hospital  OPD No 4 Department of Prasuti tantra avum Streeroga SMBT Ayurved College and Hospital Dhamangaon Nashik-422403
Nashik
MAHARASHTRA 		 08275543077

vakale96@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SMBT Ayurved College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N72||Inflammatory disease of cervix uteri. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-pratisAraNam, प्रतिसारणम् (Procedure Reference: Sushrut chikitsa 40/70, Procedure details: (Procedure Reference: Shushrut chikitsa 40/70, Procedure details: Yonidhawan – • Take patient on labour table in lithotomy position . • The yoimukha is exposed by using cusco’s speculum. • Take warm triphala kwath in yonidhawan yantra. • Make sure to kept yonidhawan yantra at proper height from ground level. • Rinse properly yoni & yoni mukha with triphala kwath with the help of yoni dahwan yantra Pradhan karma-Yonipratisaran Shushrut chikitsa 40/70 1. After Dhawan the decoction should be wiped properly by cotton swab. 2. Take cotton swab dipped into the mixture of madhu-Tankan bhasm with the help of sponge holding forcep. 3. The pratisaran is done on Garbhashay Grivagat Vrana. 4. put it there for 100 matra,it will be washed after 100 matra with nimbu swarasa 5. Sim’s speculum and AV retractor can also be used for visualization of ‘yonimukh’)) (1) Medicine Name: Tankan (Borax) madhu, Reference: Rasa tarangini trayodash tarang 61/13, Route: Vaginal, Dosage Form: Kshara, Dose: 1(g), Frequency: od, Duration: 10 Days )
(1) Medicine Name: Tankan madhu, Reference: Rasa tarangini Trayodosh tarang 61/13, Route: Vaginal, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: od, Duration: 10 Days
2Intervention ArmProcedure-pratisAraNam, प्रतिसारणम् (Procedure Reference: Sushrut chikitsa 40/70, Procedure details: (Procedure Reference: Shushrut chikitsa 40/70, Procedure details: Yonidhawan – • Take patient on labour table in lithotomy position . • The yoimukha is exposed by using cusco’s speculum. • Take warm triphala kwath in yonidhawan yantra. • Make sure to kept yonidhawan yantra at proper height from ground level. • Rinse properly yoni & yoni mukha with triphala kwath with the help of yoni dahwan yantra Pradhan karma-Yonipratisaran Shushrut chikitsa 40/70 1. After Dhawan the decoction should be wiped properly by cotton swab. 2. Take cotton swab dipped into the mixture of madhu-sharapunkha churna with the help of sponge holding forcep. 3. The pratisaran is done on Garbhashay Grivagat Vrana. 4. Sim’s speculum and AV retractor can also be used for visualization of ‘yonimukh’ ) (1) Medicine Name: Sharapunkha (Tephrosia purpurea) madhu, Reference: Bharat Bhaishajya Ratnakar bhag 5, Vrunda madhav vrana shoth 34, Route: Vaginal, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: od, Duration: 10 Days )
(1) Medicine Name: Sharapunkha (Tephrosia purpurea) madhu, Reference: Bharat Bhaishajya Ratnakar bhag 5, Vrunda madhav vrana shoth 34, Route: Vaginal, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: od, Duration: 10 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  49.00 Year(s)
Gender  Female 
Details  1.The signs and the Symptoms of Garbhashaya Grivagata Vrana like Vaginal discharge (Yonisrava), Pruritis vulvae (Yonikandu), Backache (Katishoola).

2.Age group - 18 - 49 years.

3.Married women.

4.Controlled Diabetic.
 
 
ExclusionCriteria 
Details  1.Post-natal women.
2.pregnant women.
3.unmarried women.

4.Cervical Malignancy. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction in pruritis vulvae, backache, per vaginal discharge,
size of erosion  		 10 Days 
 
Secondary Outcome  
Outcome  TimePoints 
Where the trial groups stands in comparison with control group   1st day, 5th day, 10th day 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   01/08/2024 
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 Yet Recruiting 
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  
Prevalence rate of Garbhashay grivagat vrana i.e. cervical ectopy is 15%. Ectopy is treated with cauterization, cryosurgery, laser vaporization etc. in modern science which has its own side effects. Ayurvedic treatment for managing Garbhashay grivagat vrana could be safe, non surgical , easily available and cost effective without any side effects. Sharapunkha madhu has great impact on treating Garbhashay grivagat vrana as it has Vranashodhak and vranaropak properties. Clinical trial to evaluate efficacy of sharapunkha madhu pratisaran with triphala kwath yoni dhawan would be beneficial to expand knowledge about management alternative. A clinical study of sharapunkha madhu pratisaran has not yet been assessed in Garbhashay grivagat vrana . So it will help to fill knowledge gap .
Including the married female patient having sign and symptoms of Garbhashay grivagat vrana like vaginal discharge, pruritis vulvae, backache, lower abdominal pain between age group of 18-49 year who fulfill clinical diagnostic criteria. Written consent is taken from patient to ensure ethical compliance and transparency in research process. Sample size calculated is 35 each group by using formula by Daniel 1999. Simple random sampling technique will be used. Total 70 number of patients will be divided in two group named as Group A (trial group and Group B (control group). Sharpunkha madhu pratisaran with triphala kwath yoni dhawan to group A (Trial group), tankan madhu pratisaran with triphala kwath yoni dhawan to group B (control group) will be given to patients. Drugs will be purchased from GMC certified pharmacy. Both drugs will be

administered for 10 days. All SOP of choorna preparation and Yoni Dhawan procedure will be

followed throughout the clinical trial. Observation will be done on 0th and 5th day and 10th day of treatment.

Result will be drawn on basis of assessment criteria and statistical analysis. Discussion will be done

on the basis of observation and result obtained during treatment. Summary will be drawn, and

thesis work will be summarized with the help of statistical analysis. Conclusion will be drawn out.
 
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