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CTRI Number  CTRI/2025/08/093925 [Registered on: 29/08/2025] Trial Registered Prospectively
Last Modified On: 29/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Siddha 
Study Design  Single Arm Study 
Public Title of Study   Effectiveness of Parangi Rasayanam (internal) and Padigara Neer Peechu(External) Vellai Noi (leucorrhoea)  
Scientific Title of Study   A Pilot Study On Effectiveness of Parangi Rasayanam (Internal) and Padigara Neer Peechu (External) For Vellai Noi(Leucorrhoea)  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Poonguzhal Isai kavi 
Designation  PG scholar 
Affiliation  National Institute of Siddha and Dr. MGR medical University 
Address  Sool Magalir Maruthuvam kuzhandhai Maruthuvam Op No16 17 18 National Institute of Siddha Tambaram Sanatorium Chennai 600047
National Institute of Siddha Tambaram Sanatorium Chennai 600047
Chennai
TAMIL NADU
600047
India 
Phone  9600879287  
Fax    
Email  isaikavi96bsms@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr M Meenakshi Sundaram 
Designation  Professor and HOD 
Affiliation  National Institute of Siddha 
Address  National Institute of Siddha Tambaram Sanatorium Chennai 600047
National Institute of Siddha Tambaram Sanatorium Chennai 60047
Chennai
TAMIL NADU
600047
India 
Phone  9600879287  
Fax    
Email  mmssiddha@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Poonguzhal Isai kavi 
Designation  PG scholar 
Affiliation  National Institute of Siddha 
Address  Sool Magalir Maruthuvam kuzhandhai Maruthuvam op No 16 17 18 National Institute of Siddha Tambaram Sanatorium Chennai 600047
National Institute of Siddha Tambaram Sanatorium Chennai 47
Chennai
TAMIL NADU
600047
India 
Phone  9600879287  
Fax    
Email  isaikavi96bsms@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  National Institute of siddha 
Address  National Institute of Siddha Tambaram Sanatorium Chennai 600047 
Type of Sponsor  Research institution and hospital 
 
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 
Poonguzhal Isai Kavi  Ayothidoss Pandithar hospital  Kuzhandhai Maruthuvam And Sool Magalir Maruthuvam Department Ayothidoss Pandithar hospital National Institute of Siddha Tambaram Sanatorium Chennai 600047
Kancheepuram
TAMIL NADU 		 9600879287

isaikavi96bsms@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N898||Other specified noninflammatory disorders of vagina, (2) ICD-10 Condition: N898||Other specified noninflammatory disorders of vagina,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
Intervention  Parangi Rasayanam  Parangai Rasayanam 6 gm 2 times a day Adjuvant Milk Duration 40 days Padigara Neer Peechu External Duration 40 days Ref book Agathiyar Rathina Surukkam 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Female 
Details  Women in reproductive age group
Age group: 18 to 55 years
Inclusion will be done based on leucorrhoea assessement scale
Patients who are willing to sign the informed consent
 
 
ExclusionCriteria 
Details  Pregnancy & lactation
Known case of sexually transmitted disease (Syphilis, HIV, Gonorrhoea)
Known medical history of uterine or cervical polyp
Known medical history of uterine prolapse
Known case of gardnerella vaginalis 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Significant reduction in clinical symptom which is assessed by using Leucorrhea assessment scale.  Significant reduction in clinical symptom in 40 days duration which is assessed by using Leucorrhea assessment scale. 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
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)   10/09/2025 
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="0"
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  


AIM:
    To determine the effectiveness of Parangi Rasayanam (Internal ) and Padigara neer Peechu (External ) for Vellai Noi (Leucorrhoea)
OBJECTIVES:
To assess the improvement in clinical symptoms of leucorrhoea using leucorrhoea assessment scale before and after treatment.

MATERIALS AND METHODS:
STUDY PLACE
Out Patient Department, Sool Magalir Maruthuvam,
Ayothidoss Pandithar Hospital, National institute of Siddha, Tambaram Sanatorium, Chennai -47.
STUDY PERIOD : 6 months
STUDY TYPE : Experimental STUDY DESIGN : Open clinical study SAMPLE SIZE : 10 patients
SAMPLE METHOD : Consecutive sampling method

STUDY DRUG :
Parangi Rasayanam (Internal)
Ref : Agasthiyar Rathina Surukkam.


   

DRUG STORAGE:
             The trial drug Parangi Rasayanam (internal) will be stored in clean air tight
container.
DOSAGE
       6 gm (2 times a day)
Adjuvant : Milk 
Duration : 40 days
                    Padigara Neer Peechu[6] (External)
 Duration : 40 days (3 days once)
DISPENSING:
                     The medicine will be provided from NIS OP Dispensary
SUBJECT SELECTION:
         Patients reporting with symptoms of inclusion criteria will be documented by using screening proforma.
INCLUSION CRITERIA:
Women in reproductive age group
Age group: 18 to 55 years
Inclusion will be dine based on leucorrhoea assessement scale
Patients who are willing to sign the informed consent

EXCLUSION CEITERIA:
Pregnancy & lactation
Known case of sexually transmitted disease (Syphilis, HIV, Gonorrhoea)
Known medical history of uterine or cervical polyp
Known medical history of uterine prolapse
Known case of Malignancy in uterus & ovary
Known case of gardnerella vaginalis
OUTCOME OF STUDY:
Significant reduction in clinical symptom which is assessed by using Leucorrhea assessment scale.


            ASSESSMENT SCALE[6]:
  Vaginal discharge
- No vaginal discharge
- Mild - Occasionally wetting undergarments / slight discharge, vulval moistness
- Moderate discharge, wetting of undergarments
                       3- Severe - Heavy discharge which needs vulval
Backache
- No pain
– Mild - Can withstand pain & can manage routine work
– Moderate - Cannot manage routine work & need to take rest
– Severe - Cannot withstand pain & bed ridden
            


           Itching of vulva
- No itching
- Mild - Slight rub
- Moderate - Instant rub causing redness
- Severe - Continuous rub causing redness 
      Burning of vulva
- No burning
- Mild - Occasional burning
- Moderate - Frequent burning
- Severe – Continuous
                Odour
- Absent
- Mild
- Moderate
– Severe

Symptoms
0
(None)
1
(Mild)
2
(Moderate)
3
(Severe)
Vaginal discharge








Backache








Itching of vulva








Burning of vulva








Odour











 
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