| CTRI Number |
CTRI/2024/11/077459 [Registered on: 28/11/2024] Trial Registered Prospectively |
| Last Modified On: |
05/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study in Management of Primary Dysmenorrhea |
|
Scientific Title of Study
|
A Clinical Study to Evaluate the Effect of Sauvarchaladi Gutika on Primary Dysmenorrhea |
| Trial Acronym |
ESPD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Neha Kumari |
| Designation |
P.G. Scholar |
| Affiliation |
Post Graduate Institute of Ayurved Dr S R Rajasthan Ayurved University Jodhpur Rajasthan |
| Address |
P G Department of Prasuti Tantra evam Stri Roga
Post Graduate Institute of Ayurved Dr S R Rajasthan Ayurved University Jodhpur Rajasthan
342037
India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
7976838591 |
| Fax |
|
| Email |
bundelaneha1971@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A Neelima |
| Designation |
Professor & HOD |
| Affiliation |
Post Graduate Institute of Ayurved Dr S R Rajasthan Ayurved University Jodhpur Rajasthan |
| Address |
P G Department of Prasuti Tantra evam Stri Roga
Post Graduate Institute of Ayurved Dr S R Rajasthan Ayurved University Jodhpur Rajasthan
342037
India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9610350131 |
| Fax |
|
| Email |
aspneelima@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neha Kumari |
| Designation |
P.G. Scholar |
| Affiliation |
Post Graduate Institute of Ayurved Dr S R Rajasthan Ayurved University Jodhpur Rajasthan |
| Address |
P G Deoartment of Prasuti Tantra evam Stri Roga,Post Graduate Institute of Ayurved Dr S R Rajasthan Ayurved University Jodhpur Rajasthan 342037 India JODHPUR
Rajasthan
342037
India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
7976838591 |
| Fax |
|
| Email |
bundelaneha1971@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Ayurved, Jodhpur,Rajasthan, India,
342037 |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Ayurved Jodhpur Rajasthan |
| Address |
P.G Department of Prasuti Tantra evum Stri Roga, Post Graduate Institute of Ayurved, Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur Rajasthan 342037 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Neha Kumari |
P.G Department of Prasuti Tantra evum Stri Roga, Post Graduate Institute of Ayurved, Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur Rajasthan 342037 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Neha Kumari |
Post Graduate Institute of Ayurved, Jodhpur, Rajasthan |
P G Deoartment of Prasuti Tantra evam Stri Roga
Post Graduate Institute of Ayurved Dr S R Rajasthan Ayurved University Jodhpur RAJASTHAN
342037
India
Jodhpur
RAJASTHAN |
7976838591
bundelaneha1971@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee Post Graduate Instiute of Ayurved, Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N944||Primary dysmenorrhea. Ayurveda Condition: ARTAVADOSHAH/ARTAVADUSHTIH/RAJODOSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Sauvarchaladi Gutika, Reference: Chakradutt, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Leukawarm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
1.Patients coming with chief complaint of pain during menses.
2.Patient who have menstrual score range between 1 to 12 according to WaLLID score.
3.Patients suffering with primary dysmenorrhea for more than 2 Consecutive cycles.
4.Patients in age group of Menarche to 25 years.
5.Patients with H/O using any type of analgesics during menses.
|
|
| ExclusionCriteria |
| Details |
1.Patients suffering from secondary dysmenorrhea.
2.Patients suffering from sexually transmitted infections(STI).
3.Patients suffering from systemic disease.
4.Patients having pelvic inflammatory disease.
5.Patients having organic pathology of uterus and adnexae lke fibroid uterus,carcinoma of endometrium etc. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Normal menstrual cycle without pain. |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Relief in associated features like Vomiting,fainting,headache,
lower abdominal pain,backpain,irritability,
depression |
90 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
16/12/2024 |
| 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="0"
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
|
This is single group clinical study, open label of evaluate the effect of sauvarchaladi gutika on primary dysmenorrhea. The primary outcome Normal menstrual cycle without pain with relief in associated features will be measured by subjective parameters in that pain intensity,duration of pain,nature of pain,menstrual flow duration,menstrual flow amount,WaLLID score. Here sauvarchaladi gutika will be act as Dipaniya,Shoolaprasamana, Ushanveerya, Vataanuloman,Deepan,Pachan, Rochana, Vednasthapan |