| CTRI Number |
CTRI/2025/02/080118 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
27/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the effectiveness between lodhra twak choorna and nagkeshar choorna orally with nimb dicoction yonidhavana in the management of white vaginal discharge |
|
Scientific Title of Study
|
A randomized controlled clinical study to evaluate the efficacy of lodhra twak choorna with nimb kwath yonidhavana in the management of shwetapradara in the age group of 18-45 years |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Surabhi Raju Waman |
| Designation |
PG scholer |
| Affiliation |
PDESs College of Ayurveda and research centre nigdi pune |
| Address |
PDEA College of ayurved and research centre ,third floor,streerog prasuti tantra department ,nigdi pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9527045641 |
| Fax |
|
| Email |
surabhiwaman1543@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anjali Jadhav |
| Designation |
Professor and HOD |
| Affiliation |
PDEA College of ayurved and research centre nigdi pune |
| Address |
PDEA College of ayurved and research centre,third floor,streerog prasuti tantra department,nigdi,pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9850808899 |
| Fax |
|
| Email |
anjalivijayjadhav@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anjali Jadhav |
| Designation |
Professor and HOD |
| Affiliation |
PDEA College of ayurved and research centre nigdi pune |
| Address |
PDEA College of ayurved and research centre,third floor,streerog prasuti tantra department,nigdi,pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9850808899 |
| Fax |
|
| Email |
anjalivijayjadhav@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurveda and research centre sector 25 nigdi 411044 pune maharashtra India |
|
|
Primary Sponsor
|
| Name |
PDEAs College of ayurved and research centre nigdi pune |
| Address |
PDEAS College of ayurved and research centre third floor stree rog prasuti tantra department sector 25 nigdi pradhikaran pune 411044,maharashtra India |
| Type of Sponsor |
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 Surabhi Raju Waman |
Ayurved rugnalaya and sterling multispeciality hospital |
Ayurved rugnalaya and sterling multi-speciality hospital ,stree rog prasuti tantra department 119,sector 27 pradhikarana nigdi pune 411044 India
Pune
MAHARASHTRA |
9527045641
surabhiwaman1543@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| College of ayurved and research centre nigdi Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N948||Other specified conditions associated with female genital organs and menstrual cycle. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Lodhra, Reference: Charaka Chikitsa 30/118, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -madh), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Nagakeshara, Reference: Bhavaprakash chikitsa sthan 69/11, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -madh), Additional Information: - | | 3 | Comparator Arm | Procedure | - | | (Procedure Reference: , Procedure details: )
| | 4 | Intervention Arm | Procedure | - | | (Procedure Reference: , Procedure details: )
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Married patients of age group 18-45 years who are having complaints of yonigata shwetastrava (white vaginal discharge) |
|
| ExclusionCriteria |
| Details |
1.Pregnancy and Lactation
Other pathological conditions like
2.Cervical or uterine malignancy
3.Infection like HIV.STDs
4.Use of hormonal therapy or all IUCD
5.Pelvic inflammatory disease,fibroids and polyps
6.Menorrrhagia and DUB |
|
|
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 |
| To evaluate efficacy of lodhra twak choorna and nagakeshara choorna 3 gms dose twice a day with nimb kwath yonidhavan in age group of 18-45 years unmarried females with follow up wise results before and after the treatment in cases of shwetapradara |
15 days study with follow ups on 7 th and 15 th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the efficacy of lodhra twak choorna & nagakeshara choorna in the management of shwetapradara.
To study the adverse drug reactions if any |
15 days study with follow ups on 7 th & 15 th day |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
20/02/2025 |
| 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 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
|
As per ayurveda, any problem which is related to women’s reproductive health is concerned with VATA dosha. Abnormal vaginal discharge can be physiological or pathological. It can be symptom of various diseases.Sometime this symptom can be very severe as it over shadow the actual disease. Nowadays most women complains about abnormal vaginal discharge. Prevalence of leucorrhoea is upto 27.% in women. Leucorrhoea was found significantly more in married female as compared to unmarried and lower socioeconomic status. It is very important gynacological disorder. Shwetpradar is an important gynacological disorder. Due to white discharge women prone to so many other symptoms such as bachache, itching and burning micturition. Above drugs Nimb,Lodhra and Nagakeshara are mentioned effective in shwetapradara in Charaka Chikitsa. |