| CTRI Number |
CTRI/2026/02/103706 [Registered on: 12/02/2026] Trial Registered Prospectively |
| Last Modified On: |
11/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda Preventive |
| Study Design |
Randomized, Parallel Group Trial |
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Public Title of Study
|
A comparative clinical study to evaluate the added effect of haridra and sphatika pichu with nagkeshar churna and takra in the treatment of Shwet Pradara leucorrhea
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Scientific Title of Study
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A Randomized Comparative clinical study to evaluate an add-on effect of Haridra and Sphatika (alum) pichu with nagkeshar churna and takra in the management of Shwet Pradara (leucorrhea). |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sakshi Devang |
| Designation |
PG Scholar |
| Affiliation |
PDEAs College of Ayurved and Research Centre,Nigdi ,Pune |
| Address |
PDEAs College of Ayurved and Research Centre,Nigdi,Pune
Nashik MAHARASHTRA 411044 India |
| Phone |
7756063721 |
| Fax |
|
| Email |
devangsd2000@gmail.com |
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Details of Contact Person Scientific Query
|
| Name |
Dr Anjali Jadhav |
| Designation |
Professor and HOD |
| Affiliation |
PDEAs College of Ayurved and Research Centre,Nigdi,Pune |
| Address |
PDEAs College of Ayurved and Research Centre,Nigdi,Pune
Pune MAHARASHTRA 411044 India |
| Phone |
9850808899 |
| Fax |
|
| Email |
anjalivijayjadhav@gmail.com |
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Details of Contact Person Public Query
|
| Name |
Dr Anjali Jadhav |
| Designation |
Professor and HOD |
| Affiliation |
PDEAs College of Ayurved and Research Centre,Nigdi,Pune |
| Address |
PDEAs College of Ayurved and Research Centre,Nigdi,Pune
Pune MAHARASHTRA 411044 India |
| Phone |
9850808899 |
| Fax |
|
| Email |
anjalivijayjadhav@gmail.com |
|
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Source of Monetary or Material Support
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| PDEAs College of Ayurveda and Research Centre, Sector 25, Pradhikaran ,Nigdi ,Pune 411044 |
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Primary Sponsor
|
| Name |
PDEAs College of Ayurveda and Research Centre, Nigdi Pune |
| Address |
PDEAs College of Ayurveda and Research Centre, Streerog department,Nigdi Pune MAHARASHTRA 411044 India |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sakshi Devang |
Ayurveda Rugnalay and Sterling Multispeciality Hospital Nigdi, Pradhikaran, Pune |
Ayurveda Rugnalay and sterling multispeciality hospital Nigdi Pradhikaran Pune sector 27 Streerog Department OPD NO 119 Pune Pune MAHARASHTRA |
7756063721
devangsd2000@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Chairperson Institutional Ethics Committeee |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N899||Noninflammatory disorder of vagina, unspecified. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: nagkeshar churna, Reference: bhavaprakash chikitsa 69, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -takra), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: nagkeshar churna, Reference: bhavprakash chikitsa sthan 69/11, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -takra), Additional Information: - | | 3 | Intervention Arm | Procedure | - | yoni picu, योनि पिचु | (Procedure Reference: charak chikitsa 30, Procedure details: Procedure details: Sterile speculum inserted in the vagina . medicated pichu placed inside vagina under aseptic precautions . Ensure proper placement near cervical canal. Pichu kept inside vagina for approximately 3 hours daily for 7 days.)) (1) Medicine Name: haridra, Reference: dhanvantari nighantu 55, Route: Vaginal, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: od, Duration: 7 Days(2) Medicine Name: sphatik, Reference: raj nighantu 118, Route: Vaginal, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: od, Duration: 7 Days |
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Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Married patient of age group 19-45 who are having c/o yonigata shwetastrava(white vaginal discharge) |
|
| ExclusionCriteria |
| Details |
1. Pregnant women
Known case of-
2. Cervical or uterine malignancy
3. Human immunodeficiency viruses
4. Sexually transmitted diseases
5. Uterine fibroid
6. Uterine polyp
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Method of Generating Random Sequence
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Coin toss, Lottery, toss of dice, shuffling cards etc |
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Method of Concealment
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Alternation |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy of Haridra and Turti Pichu as an add on therapy to Nagkeshar Churna and Takra in reducing vaginal discharge, itching, discomfort in patients with Shweta Pradara in time duration of 30 days.
|
To compare the efficacy of Haridra and Turti Pichu as an add on therapy to Nagkeshar Churna and Takra in reducing vaginal discharge, itching, discomfort in patients with Shweta Pradara in time duration of 30 days.
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| To observe & compare the adverse effect within 30 days if any |
30 days treatment |
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Target Sample Size
|
Total Sample Size="35" Sample Size from India="35"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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N/A |
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Date of First Enrollment (India)
|
25/02/2026 |
| 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 |
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Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
This study aims to evaluate the add on effect of Haridra and Sphatika pichu with Nagkeshar churna and takra in the management of Shwet Pradara which is comparable to leucorrhea. Shwet Pradara is a common gynecological complaint in women of reproductive age characterized by excessive white vaginal discharge and is mainly associated with vitiation of Kapha dosha. Conventional treatment provides temporary relief and recurrence is common therefore there is a need for safe and effective Ayurvedic management.
The study is designed as a randomized comparative clinical trial including seventy patients suffering from Shwet Pradara. Patients will be divided into two groups. Group A will receive Nagkeshar churna with takra orally. Group B will receive Nagkeshar churna with takra along with Haridra and Sphatika pichu as local therapy. Treatment duration will be seven days with follow up on fifteenth and thirteeth day.
The objective of the study is to compare the effectiveness of combined internal and external Ayurvedic therapy in reducing symptoms such as vaginal discharge itching burning micturition and lower backache. The study also aims to observe any adverse effects and evaluate overall improvement.
Assessment will be done using subjective and objective clinical parameters. Statistical analysis will be performed to compare the results between both groups. This study is expected to provide clinical evidence for a holistic Ayurvedic approach in the management of Shwet Pradara and help in reducing recurrence and improving quality of life in affected women.
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