| CTRI Number |
CTRI/2026/01/100954 [Registered on: 13/01/2026] Trial Registered Prospectively |
| Last Modified On: |
13/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To evaluate the drug efficacy of lashunadi vati in udavartini yonivyapad with special reference to Primary dysmenorrhoea |
|
Scientific Title of Study
|
Randomized Controlled Clinical Study To Evaluate The Efficacy Of Lashunadi Vati In The Management Of Udavartini Yonivyapad With Special Reference To Primary Dysmenorrhoea |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shivani Ravindra Tuptewar |
| Designation |
PG Scholar |
| Affiliation |
Siddhakala Ayurveda college and research center sangamner |
| Address |
Ground floor OPD No 5 , Streeroga Avum Prasutitantra Department , Siddhakala Ayurved Mahavidyalaya , Pimparane Road , Sangamner Khurd , Sangamner , Ahilyanagar , Maharashtra , 422605
Ground floor OPD No 5 , Streeroga Avum Prasutitantra Department , Siddhakala Ayurved Mahavidyalaya , Pimparane Road , Sangamner Khurd , Sangamner , Ahilyanagar , Maharashtra , 422605
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
7218781199 |
| Fax |
|
| Email |
shivanituptewar2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vipul Vishwanath Bhujbal |
| Designation |
HOD Of Streeroga Avum Prasutitantra |
| Affiliation |
Siddhakala Ayurveda College and Research Center Sangamner |
| Address |
Ground floor OPD No 5 , Streeroga Avum Prasutitantra Department , Siddhakala Ayurved Mahavidyalaya , Pimparane Road , Sangamner Khurd , Sangamner , Ahilyanagar , Maharashtra , 422605
Ground floor OPD No 5 , Streeroga Avum Prasutitantra Department , Siddhakala Ayurved Mahavidyalaya , Pimparane Road , Sangamner Khurd , Sangamner , Ahilyanagar , Maharashtra , 422605
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9960840214 |
| Fax |
|
| Email |
vipulbhujbal1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shivani Ravindra Tuptewar |
| Designation |
PG Scholar |
| Affiliation |
Siddhakala Ayurveda college and Research Center Sangamner |
| Address |
Ground floor OPD No 5 , Streeroga Avum Prasutitantra Department , Siddhakala Ayurved Mahavidyalaya , Pimparane Road , Sangamner Khurd , Sangamner , Ahilyanagar , Maharashtra , 422605
Ground floor OPD No 5 , Streeroga Avum Prasutitantra Department , Siddhakala Ayurved Mahavidyalaya , Pimparane Road , Sangamner Khurd , Sangamner , Ahilyanagar , Maharashtra , 422605
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
7218781199 |
| Fax |
|
| Email |
shivanituptewar2000@gmail.com |
|
|
Source of Monetary or Material Support
|
| Siddhakala Ayurved Mahavidyalaya , Pimparane Road , Sangamner Khurd , Sangamner, Ahilyanagar , Maharashtra, India , Pincode - 422605 |
|
|
Primary Sponsor
|
| Name |
Dr Shivani Ravindra Tuptewar |
| Address |
Siddhakala Ayurved Mahavidyalaya , Pimparane Road , Sangamner Khurd , Sangamner, Ahilyanagar , Maharashtra, India , Pincode - 422605 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Shivani Ravindra Tuptewar |
Siddhakala Ayurveda Mahavidyalay And Hospital,Pimparne Road, Sangmaner |
Ground floor OPD No 5 , Streeroga Avum Prasutitantra Department , Siddhakala Ayurved Mahavidyalaya , Pimparane Road , Sangamner Khurd , Sangamner , Ahilyanagar , Maharashtra , 422605
Ahmadnagar
MAHARASHTRA |
7218781199
shivanituptewar2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Board Of Research And Statistics Committee Of Siddhakala Ayurved Mahavidyalaya , Sangamner |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N944||Primary dysmenorrhea. Ayurveda Condition: UDAVARTINI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Rajapravartini Vati, Reference: Bhaishajya ratnavali , Yonivyapad Chikitsa Adhyay , Chapter No-58 , Shloka No- 59, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Koshna Jal), Additional Information: Rajapravartini Vati 250 mg BD Early Morning And Evening Before Meal With Koshna jal for Three Consecutive Menstrual Cycles. | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Lashunadi vati , Reference: Vaidyajeevan, Lolimbraj, Chaturth vilas,Kshayadigadanam chikitsa adhyay, Shloka no 13, Page no. 97, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -koshna jala), Additional Information: - Early Morning and Evening before meal for three consecutive menstrual cycles |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
1.Patients on hormonal therapy.
2.Pelvic Inflammatory Disease, uterine fibroid, Adenomyosis.
3.Known case of structural anomalies of genital tract.
4.Known case of immune compressive diseases like HIV, HBsAg. |
|
| ExclusionCriteria |
| Details |
1. Patients on hormonal therapy.
2. Pelvic Inflammatory Disease, uterine fibroid, Adenomyosis.
3. Known case of structural anomalies of genital tract.
4. Known case of immune compressive diseases like HIV , HBsAg.
5. Known case of life style disorders like DM, HTN, PCOD, Thyroid
abnormalities |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study in detail the rate and extent of pain relief after the oral administration of Lashunadi vati 250mg BD for consecutive 3 menstrual cycles. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-To assess any adverse reaction or side effect related to the oral administration of Lashunadi vati.
-To introduce effective ayurvedic medicine for Udavartini yonivyapad. |
3 months |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
10/02/2026 |
| 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 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This Study is Randomized Open Labelled Controlled Clinical Trial Comparing the Safety and Efficacy of Lashunadi Vati 250 mg BD With Koshna Jal Before Meal And Controlled Drug Rajapravartini Vati 250 mg BD With Koshna Jal Before Meal For 3 Consecutive Menstrual Cycles in 110 Patient of Udavartini Yonivyapad Divided In 2 Groups And Observed VAS NRS Scale. |