| CTRI Number |
CTRI/2026/01/100099 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
30/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study TO Rule out efficasy Between Amalaki Churna And Lodhra Churna In The Management Of Shwetpradara (Leucorrhea) |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL TRIAL DETERMINE THE EFFICACY OF AMALAKI CHURNA AND LODHRA CHURNA IN THE MANAGEMENT OF SHWETPRADARA (LEUCORREA) |
| 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 Sandeep natha jadhav |
| Designation |
Post Graduate scholer |
| Affiliation |
Ashvin Rural Ayurved College Manchi Hill Sangamner |
| Address |
prasutitanta and strirog department ashvin rural ayurved college and hospital sadvi preetisudhaji maharaj nagar manchi hill ashvi bk tal sangamner dist ahmadnagar
MAHARASTRA
413714
India
Ahmadnagar
MAHARASHTRA
413714
India |
| Phone |
9146589877 |
| Fax |
|
| Email |
sandeeptijadhav7747@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep natha jadhav |
| Designation |
Post Graduate scholer |
| Affiliation |
Ashvin Rural Ayurved College Manchi Hill Sangamner |
| Address |
prasutitanta and strirog department ashvin rural ayurved college and hospital sadvi preetisudhaji maharaj nagar manchi hill ashvi bk tal sangamner dist ahmadnagar
MAHARASTRA
413714
India
Ahmadnagar
MAHARASHTRA
413714
India |
| Phone |
9146589877 |
| Fax |
|
| Email |
sandeeptijadhav7747@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vidhya Sarode |
| Designation |
HOD |
| Affiliation |
Ashvin Rural Ayurved College Manchi Hill Sangamner |
| Address |
prasutitanta and strirog department ashvin rural ayurved college and hospital sadvi preetisudhaji maharaj nagar manchi hill ashvi bk tal sangamner dist ahmadnagar
MAHARASTRA
413714
India
Ahmadnagar
MAHARASHTRA
413714
India |
| Phone |
8975019105 |
| Fax |
|
| Email |
vidhya.sarode18@gmail.com |
|
|
Source of Monetary or Material Support
|
| Prasutitantra And Strirog Deparmnent OPD And IPD Ashvin Rural Ayurved College And Hospital Manchi Hill Ashvi Bk Sangamner Dist Ahmadnagar State Maharastra India 413714 |
|
|
Primary Sponsor
|
| Name |
Dr.Sandeep Natha Jadhav |
| Address |
prasutitanta and strirog department ashvin rural ayurved college and hospital sadvi preetisudhaji maharaj nagar manchi hill ashvi bk tal sangamner dist ahmadnagar
MAHARASTRA
413714
India |
| Type of Sponsor |
Other [self ] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Nill |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sandeep Natha Jadhav |
Ashvin Rural Ayurved College And Hospital |
Prasutitanta And Strirog Department Ashvin Rural Ayurved College and Hospital Sadvi Preetisudhaji Maharaj Nagar Manchi Hill Ashvi Bk Tal Sangamner Dist Ahmadnagar
MAHARASTRA
413714
India
Ahmadnagar
MAHARASHTRA |
9146589877
sandeeptijadhav7747@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ashvin rural ayurved college Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N898||Other specified noninflammatory disorders of vagina. Ayurveda Condition: ARTAVADOSHAH/ARTAVADUSHTIH/RAJODOSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Lodhra Churna , Reference: Charak Chikisthan 30/117-118, Route: Oral, Dosage Form: Churna/ Powder, Dose: 4(g), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Amalaki Churna , Reference: Charak Chikitsthan 30/116, Route: Oral, Dosage Form: Churna/ Powder, Dose: 4(g), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1) Age group 18-35 years
2) Female Patients having symptoms - Yoni kandu (itching vulva) ,Yoni daha (burning sensation of vulva),Shwetasrava(WhiteVaginalDischarge) ,Daurgandhya(Foul-smelling of discharge),Katishool (Backache)
3) Willing for participation or ready to give Informed consent. |
|
| ExclusionCriteria |
| Details |
1)Female Patients aged below 18 years and above 35 years
will be excluded.
2)K/C/O women with Diabetes Mellitus.
3)Pregnant & lactating mothers.
4) K/C/O C.A. of genital organs, uterine tumor or uterine
Prolapse
5)K/C/O Sexually transmitted diseases .
6) patient with K/C/O systemic diseases like HIV and severe
Anemia. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Amalaki Churna Is Significantly Effective Than Lodhra Churna In The Management Of Shwetpradara |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease Symptoms Of Shwetpradara |
7 Days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 |
|
Date of First Enrollment (India)
|
14/01/2026 |
| 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
|
Shwetpradara is one of the most common problem faced by women at all ages characterized by White Vaginal discharge. Shwetpradara is not a disease , but it is an annoying symptom which is present in many gynecological disorders. Shwet means white in colour and Pradar means increased quantity which in Combined called as excessive white discharge per Vagina 1.
There is no direct mention of Shwetpradara in Brihatrayee, but has been described in Sharangadhar Samhita , Yog Ratnakar ,Bhavprakash and in commentary on Charaka Samhita by Chakrapani. Shwetpradara is seen as a symptom of various types of Yonivyapada. Acharya Charaka stated that Symptoms of kaphaja yonivyapad can be correlated with Shwetpradara as Pichchila , sheeta , panduvarna , kandu yukta and alpavedna yukta yoni strava . Considering clinical features of Shwetpradar , it is kaphaja disorder in the region of apana vaayu as any type of strava (discharge) is resulted from kaphaj dosha 2 .
in this study randomly sixty patient selected from opd and ipd of Ashvin Rural Ayurveda college and hospital manchi hill sangamner. divided in two groups. Group A and Group B.
Group A trail amlaki churn with madhu and Group B trail lodhra churna with madhu. thirty patient in each group will studied. study will be conducted in India and Outcome will ne assesed. |