| CTRI Number |
CTRI/2025/08/092232 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
01/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
This study will find out if a traditional medicine called Nagaradi Gutika can help reduce pain and other symptoms in women who have a condition that causes menstrual cramps. |
|
Scientific Title of Study
|
RANDOMISED CONTROLLED CLINICAL TRIAL TO STUDY THE EFFECT OF NAGARADI GUTIKA IN THE MANAGEMENT OF UDAVARTINI YONIVYAPAD W.S.R 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 |
Dr Rajgauri Appasaheb Mengawade |
| Designation |
PG Student Streeroga Prasutitantra |
| Affiliation |
Matoshree Asarabai Darade Ayurveda Mahavidyalaya |
| Address |
Department of Streeroga and Prasutitantra Matoshree Asarabai Darade Ayurveda
Mahavidyalaya Bhabulgaon Tal- Yeola Dist- Nashik Maharashtra Pin -423401
Nashik
MAHARASHTRA
423401
India |
| Phone |
9373422896 |
| Fax |
|
| Email |
rajgauree@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Limbanappa Garthe |
| Designation |
Professor HOD and Guide |
| Affiliation |
Matoshree Asarabai Darade Ayurveda Mahavidyalaya |
| Address |
Department of Streeroga and Prasutitantra Matoshree Asarabai Darade Ayurveda
Mahavidyalaya Bhabulgaon Tal- Yeola Dist- Nashik Maharashtra Pin -423401
Mahavidyalaya Bhabulgaon Tal- Yeola Dist- Nashik Maharashtra Pin -423401
Nashik
MAHARASHTRA
423401
India |
| Phone |
9822315561 |
| Fax |
|
| Email |
lsgarthe@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Limbanappa Garthe |
| Designation |
Professor HOD and Guide |
| Affiliation |
Matoshree Asarabai Darade Ayurveda Mahavidyalaya |
| Address |
Department of Streeroga and Prasutitantra Matoshree Asarabai Darade Ayurveda
Mahavidyalaya Bhabulgaon Tal- Yeola Dist- Nashik Maharashtra Pin -423401
Mahavidyalaya Bhabulgaon Tal- Yeola Dist- Nashik Maharashtra Pin -423401
Nashik
MAHARASHTRA
423401
India |
| Phone |
9822315561 |
| Fax |
|
| Email |
lsgarthe@gmail.com |
|
|
Source of Monetary or Material Support
|
| Matoshree Asarabai Darade Ayurveda Mahavidyalaya Bhabulgaon Tal- Yeola Dist- Nashik
Maharashtra Pin -423401 |
|
|
Primary Sponsor
|
| Name |
Dr Rajgauri Appasaheb Mengawade |
| Address |
Matoshree Asarabai Darade Ayurveda Mahavidyalaya Bhabulgaon Tal- Yeola
Dist- Nashik Maharashtra Pin -423401 |
| 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 Rajgauri Appasaheb Mengawade |
Matoshree Asarabai Darade Ayurveda Mahavidyalaya Bhabulgaon Tal-Yeola |
Streeroga Prasutitantra Opd No 8 Ground Floor Nashik Maharashtra Nashik MAHARASHTRA
Nashik
MAHARASHTRA |
9373422896
rajgauree@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E20-E35||Disorders of other endocrine glands. Ayurveda Condition: UDAVARTINI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Nagaradi Gutika, Reference: Charak Chikista Gulma Chikista 5/91 Shlok 12, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Ushna Dughda), Additional Information: From 1st to 5th day of menstruation for 3 consecutive cycle | | 2 | Comparator Arm (Non Ayurveda) | | - | Tablets Nobel Spas New | Contains :- 1) Drotaverine Hydro chloride 80 MG 2) Aceclofenac IP 100 MG ; BD from 1st day to 3rd day of menstruation for 3 consecutive cycles |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
25.00 Day(s) |
| Gender |
Female |
| Details |
1.Patients willing to participate in the study.
2.Patients having classical signs and symptoms of Udavartini Yonivyapad.
3.Females of age group 18–25 years.
4.Painful menstruation for at least 3 consecutive cycles.
5.Regular menstruation cycle ranging from 21 to 35 days with normal bleeding 3–7 days.
6.Patients who have not taken any medication for dysmenorrhea like OC pills for the last 3 months. |
|
| ExclusionCriteria |
| Details |
The following individuals will be excluded from the study:
1. Patients with any systemic illness, including:
Hypertension
Diabetes Mellitus
Hyperthyroidism or Hypothyroidism
Renal disorders
Hepatic (liver) disorders
Sexually transmitted diseases
Appendicitis
2.Patients exhibiting hysterical behavior or diagnosed with hysteria.
3.Patients with congenital anomalies or structural abnormalities.
4.Patients with severe anemia (Hemoglobin level < 7 gm%).
5.Patients experiencing abdominal pain associated with:
Excessive vaginal bleeding
Endometriosis
Pelvic Inflammatory Disease (PID)
Uterine fibroids
Ovarian cysts or similar pelvic pathologies
6.Patients currently using intrauterine contraceptive devices (IUCDs). |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the efficacy of Nagaradi Gutika in Udavartini Yonivyapad with special reference to Primary Dysmenorrhea |
1 weeks ,4 weeks,
4months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare the efficacy of Nagaradi Gutika and Noble Spas in Udavartini Yonivyapad, with special reference to Primary Dysmenorrhea.
2.To review Udavartini Yonivyapad from Ayurvedic Samhitas.
3.To observe the efficacy of Nagaradi Gutika in Udavartini Yonivyapad |
1 week,4weeks,
4months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
12/08/2025 |
| 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="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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [rajgauree@gmail.com].
- For how long will this data be available start date provided 11-08-2025 and end date provided 11-08-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This is Randomized open controlled clinical study to evaluate the efficacy of Nagaradi Gutika in the management of painful menstruation that will be conducted in OPD of Matoshree Asarabai Darade Ayurveda Mahavidyalaya Bhabulgaon. The primary outcome measures will be to assess the effect of drug after 5days and 4 weeks and secondary outcomes will be measured after 3 menstrual cycles during treatment and after 1 month after the treatment is completed. |