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CTRI Number  CTRI/2025/02/080855 [Registered on: 18/02/2025] Trial Registered Prospectively
Last Modified On: 17/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Clinical Study to Evaluate the Effect of Lajjalu Kwatha Pana along with Veshwara Pinda Dharana in Yoni Stramsa w.s.r Ist Degree Genital Prolapse . 
Scientific Title of Study   A Controlled Clinical Study to Evaluate the Effect of Lajjalu Kwatha Pana along with Veshwara Pinda Dharana in Yoni Stramsa w.s.r Ist Degree Genital Prolapse . 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aarthi Stanly Nadar 
Designation  MS Scholar Prasuti tantra and Striroga. 
Affiliation  M.A Podar Ayurvedic hospital,Mumbai 
Address  Prasuti tantra and stri roga opd.no.8 .M.A Podar govt.Ayurvedic Hospital ,Worli,Mumbai,Maharashtra- 400018

Mumbai
MAHARASHTRA
400018
India 
Phone  8208191530  
Fax    
Email  aarthinadar1997@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Prashant Dalvi 
Designation  Associate Professor (Prasuti tantra and stri roga 
Affiliation  M.A Podar Ayurvedic hospital,Mumbai 
Address  Prasuti tantra and stri roga opd.no.8 .M.A Podar govt.Ayurvedic Hospital ,Worli,Mumbai,Maharashtra- 400018

Mumbai
MAHARASHTRA
400018
India 
Phone  9822783636  
Fax    
Email  drdalvipn@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Prashant Dalvi 
Designation  Associate Professor (Prasuti tantra and stri roga 
Affiliation  M.A Podar Ayurvedic hospital,Mumbai 
Address  Prasuti tantra and stri roga opd.no.8 .M.A Podar govt.Ayurvedic Hospital ,Worli,Mumbai,Maharashtra- 400018

Mumbai
MAHARASHTRA
400018
India 
Phone  9822783636  
Fax    
Email  drdalvipn@gmail,com  
 
Source of Monetary or Material Support  
MA Podar Ayurvedic hospital ,Mumbai,worli,-400018 
 
Primary Sponsor  
Name  Aarthi Stanly Nadar 
Address  OPD no.8,MA Podar Ayurvedic Hospital, Worli ,Dadar Mumbai Maharashtra -400018 
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 Aarthi Nadar  MA Podar Ayurvedic hospital   OPD.no.8 prasuti striroga vibhaga MA Podar Ayurvedic Hospital,Mumbai,Worli
Mumbai
MAHARASHTRA 		 8208191530

aarthinadar1997@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC,RA Podar Ayurvedic Medical College,Mumbai,Worli  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N819||Female genital prolapse, unspecified. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-Yonipichu (Procedure Reference: Sushrut , Procedure details: Once a day for 7 days )
(1) Medicine Name: Veshwara , Reference: Sushrut , Route: Vaginal, Dosage Form: Kalka/ Paste, Dose: 25(g), Frequency: od, Duration: 7 Days
2Intervention ArmDrugClassical(1) Medicine Name: Lajjalukwath , Reference: Sushrut , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -
3Comparator ArmProcedure-yoni picu, योनि पिचु (Procedure Reference: Sushrut , Procedure details: Once a day for 7 days )
(1) Medicine Name: Veshwara pind , Reference: Sushrut , Route: Vaginal, Dosage Form: Kalka/ Paste, Dose: 25(g), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1. Married female parous women age group of 25-45 year with complaint of something coming out per vaginum.
2. First degree genital prolapse. (Prasramsini yonivyapad) 
 
ExclusionCriteria 
Details  ) Pregnant women

2) Local gynaecological causes like ovarian cyst, prolapse, fibromyoma, polyps.

3) Neoplasm (Cervical or uterine malignancy)

4) patients with bleeding disorders

5) Those suffering from congenital anomalies of genital tract

6) Pelvic inflammatory diseases

7) Patients with sexually transmitted diseases

8) Abnormal uterine bleeding

9) Patients with severe hepatic or cardiac or renal disorders

10) Those having leukaemia or platelet deficiency disorders

11) Females in their puerperium period

12) Patient with severe anaemia

13) HIV HbsAg VDRL,HPV positive patients

14) Patients with DM,HTN

15)Patient with other diseases like epilepsy, asthma, PTB.etc.

16) Patient with paychosis and organic brain damage. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To Evaluate the efficacy of veshwara pinda dharan and lajjalu kwathin yoni stramsa.

2..To Study what changes in Balden walker classification observed by using veshwara pinda and lajjalu kwatha pana.

3. To Compare the effect of lajjalu kwatha pana with veshwara pindha dharana with veshwara pinda dharana only.


 		 7 DAYS 
 
Secondary Outcome  
Outcome  TimePoints 
the efficacy of veshwara pinddharan & lajalukwathpan is more than only with veshwara pinddharan alone in
yonistramsa ( 1st degree genital prolapse).
Symptoms of urinary incontinence,backache,yoni
daha will be reduced. 		 7 days  
 
Target Sample Size   Total Sample Size="34"
Sample Size from India="34" 
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)   28/02/2025 
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   OBJECTIVE: To Evaluate the effect of lajjalu kwatha pana along with Veshwara Pinda dharana in Yoni stramsa w.s.r to Ist Degree Genital Prolapse.
Approximately 68 patients are selected.
Group A-Lajjalu kwatha pana along with Veshwara pinda dharana
Group b -Veshwara Pinda dharana
Selection of Patients: Patient having complaints of something coming of vagina fulfilling inclusion criteria is taken for study.
Assessment of symptoms: Patient will be assessed monthly after menses for 3 cycles.,and procedure will be done for 7 days.

follow up will  be taken after cessation of menses for 3 cycle,to know whether subjective and objective criteria being fulfilled.
Assesment Criteria:The Study will be strictly based on assesment of subjective parameter and objective parameter.
The data obtained will be analysed statistically.
objective criteria will be classified according to balden-walker  classification.
Conclusion:
The Result will be recorded before and after treatment and conclusion will be drawn on the basis of statisticla Analysis.
End point:
1.There will be significant decrease in something coming out of vagina by using veshwara pinda dharana along with lajjalu kwatha pana .
2.Comparative  Reduction in something coming out of vagina,yoni daha, yoni starva and backache with veshwara pinda dharana along with Lajjalu kwathapana.
 
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