| CTRI Number |
CTRI/2025/08/092505 [Registered on: 06/08/2025] Trial Registered Prospectively |
| Last Modified On: |
05/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
TO assess the effect of Patrangasava with and without chandraprabhavati in white Discharge. |
|
Scientific Title of Study
|
AN OPEN LABELTWO ARM CLINICAL STUDY TO EVALUATE THE EFFICACY OF PATARANGASAVA WITH AND WITHOUT CHANDRAPRABHA VATI IN SHWETA PRADARA W.S.R. TO LEUCORRHOE
|
| 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 Kajal Mishra |
| Designation |
PG Scholar |
| Affiliation |
SHRI BABU SINGH JAY SINGH AYURVEDIC MEDICAL COLLEGE AND HOSPITAL FARRUKHABAD |
| Address |
Shri Babu Singh Jay Singh Ayurvedic Medical College And Hospital Farukhabad UP
Shri Babu Singh Jay Singh Ayurvedic Medical College AND Hospital Farrukhabad UP
Farrukhabad
UTTAR PRADESH
209602
India |
| Phone |
7991242603 |
| Fax |
|
| Email |
1995kajal07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bandana Devi |
| Designation |
Associate Professor |
| Affiliation |
SHRE BABU SINGH JAY SINGH AYURVEDIC MEDICAL COLLEGE AND HOSPITAL FARRUKHABAD UP |
| Address |
SHRE BABU SINGH JAY SINGH AYURVEDIC MEDICAL COLLEGE AND HOSPITAL BHAUPUR FARRUKHABAD UP
Shri Babu Singh Jay Singh Ayurvedic Medical College And Hospital Farukhabad UP
Farrukhabad
UTTAR PRADESH
209602
India |
| Phone |
7905200409 |
| Fax |
|
| Email |
bandanapatel01@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kajal Mishra |
| Designation |
PG Scholar |
| Affiliation |
Shri Babu Singh Jay Singh Ayurvedic Medical College And Hospital Farukhabad UP |
| Address |
Shri Babu Singh Jay Singh Ayurvedic Medical College And Hospital Farukhabad UP
Shri Babu Singh Jay Singh Ayurvedic Medical College And Hospital Farukhabad UP
Farrukhabad
UTTAR PRADESH
209602
India |
| Phone |
7991242603 |
| Fax |
|
| Email |
1995kajal07@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Babu Singh Jay Singh Ayurvedic Medical College And Hospital Farukhabad UP |
|
|
Primary Sponsor
|
| Name |
Dr Kajal Mishra |
| Address |
Shri Babu Singh Jay Singh Ayurvedic Medical College And Hospital Farukhabad UP |
| Type of Sponsor |
Other [Private Medical College] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR Kajal Mishra |
Shri Babu Singh Jay Singh Ayurvedic Medical College And Hospital |
Prasuti Tantra Stree Roga Department OPD No 10 Bhaupur Farrukhabad
Farrukhabad
UTTAR PRADESH |
07991242603
1995kajal07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:8||Other Procedures. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Patrangasava, Reference: Baisajyaratnavali, Route: Oral, Dosage Form: Asava, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: Rqual quantity of water), Additional Information: NO | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Candraprabha Vati, Reference: Bhaisajyaratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: Given with Patarangasava |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1.Subjects between the age group 16 to 50 years.
2.Subjects having classical signs and symptoms of Shweta Pradara.
3.Subjects full filling the diagnostic criteria vaginal discharge with and without itching.
|
|
| ExclusionCriteria |
| Details |
1.Subjects less than 16 yrs and more than 50 yrs of age.
2.Pregnant and lactating women.
3.Known case of HTN, DM.
4.Prolapsed Uterus.
5.Subjects positive for HIV, VDRL, HBsAg, HCV.
Subjects suffering from any type of malignancy, cervical malignancy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of Patrangasava in Shweta Pradara |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effect of Patrangasava With Chandraprabha Vati in Shweta Pradara |
21 DAYS |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
30/08/2025 |
| 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="0"
Days="21" |
|
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
|
Shweta Pradara is one of the commonest
symptoms reported by women of
reproductive age.[1]In Ayurveda,
Leucorrhoea is known as Shweta Pradara where
Shweta means white and Pradara means discharge. Due to increase Kapha Dosha and imbalance of Rasa Dhatu or dushti of Apaan Vayu cause excessive white discharge threw vaginal
tract.
Shweta Pradara is a condition in which
there is a whitish discharge from the
vagina. It may be thick and viscid and foul smelling
when it is caused by some infection. Ayurveda says that due to intake of Kapha predominant Aahar-Vihar the Kapha
dosha get vitiated. Consequently the Kapha
reaches Yoni by aggravated Apana vayu and due to its physical and
chemical characteristics, white coloured, thick and thin, foul-smelling fluid
called abnormal vaginal discharge. It can also be due to the inflammation of
the womb following childbirth, displacement of the Uterus. Among young females,
it may be due to threadworm infection, as the result of general debility
combined with lack of cleanliness or infections.
Leucorrhoea
is a white discharge from the vagina. Vaginal discharge occurs in
regular variations of amount and consistency during
the course of the menstrual cycle. A greater then usual amount is normal in
pregnancy and a decrease is to be expected after delivery, during lactation and
after menopause. It is may be physiological or pathological. Physiological
vaginal discharge does not require any treatment. But the pathological
condition which necessitate treatment are those involving many infections.
The World Health Organization
estimated that in a period of one year, there are 333 million new cases of
Vulvo – Vaginal Infection which are curable if addressed at the right time. A
study in India has shown the prevalence of reproductive tract infections was
37.0% based on symptoms and 36.7% by laboratory investigations.[2]
Leucorrhoea
signs and symptoms are similar to those of Shweta
Pradara, which
is mentioned in classics. Kapha is the primary dosha that causes Shweta Pradara. The drugs which are having Tridosha shamaka
especially Kaphahara, Stambhana, Vedana sthapana, Balya, Krimighna, Kanduhara properties are selected for
the management of Shweta Pradara w.s.r. to Leucorrhoea.
World
is looking towords Ayurveda with hope for remedies because the treatment
modalities in the Allopathic medicine have
unsatisfactory results. They have also some side effects. So there is a great
scope for research to find out safe, potent, effective and less costly remedy
of Ayurveda for management of Shweta
Pradara w.s.r. to Leucorrhoea.
So here in this
study we are using PATRANGASAVA with
and without CHANDRAPRABHA VATI. |