| CTRI Number |
CTRI/2020/01/022673 [Registered on: 09/01/2020] Trial Registered Prospectively |
| Last Modified On: |
20/12/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study the effect of Sundari Jeevak syrup in Kashtartava (Primary dysmenorrhea) |
|
Scientific Title of Study
|
An open label clinical trial to evaluate the efficacy of Sundari Jeevak syrup in the management of Kashtartava (Primary dysmenorrhea) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Not Registered elsewere |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gopesh Mangal |
| Designation |
Associate Professor |
| Affiliation |
NIA,Jaipur |
| Address |
Department of Panchkarma National Institute of Ayurveda, Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
8619849011 |
| Fax |
|
| Email |
gmangal108@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Himanshu Shekhar Tiwari |
| Designation |
Medical Advisor Multani Pharmaceuticals Ltd |
| Affiliation |
Multani Pharmaceuticals Ltd. |
| Address |
Medical advisor room, Pharmacy division, Multani Pharmaceuticals Ltd. New Delhi
New Delhi
DELHI
110020
India |
| Phone |
9654350714 |
| Fax |
|
| Email |
dr.hstiwari@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Hetal H Dave |
| Designation |
Assistant Professor |
| Affiliation |
NIA,Jaipur |
| Address |
Department of Stri- Prasuti National Institute of Ayurveda, Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
09691226829 |
| Fax |
|
| Email |
hetaldave2406@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Multani Pharmaceuticals Ltd |
| Address |
Multani Pharmaceuticals Ltd, New Delhi. Address: T-10 Okhla Phase II Road, Pocket W. Okhla Industrial Area New Delhi- 110020 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Gopesh Mangal |
National institute of Ayurveda |
OPD room no 2, room 26 and IPD of Panchakarma Department
Jaipur
RAJASTHAN |
8619849011
gmangal108@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Institute of Ayurveda, IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N944||Primary dysmenorrhea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Sundari Jeevak Syrup |
Sundari Jeevak syrup 20 ml before meal thrice a day orallywill be given 14 days after menstruation till the commencement of next cycle for two consecutive cycle. |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
1. Females suffering from primary dysmenorrhea more than 3 consecutive cycles.
2. Female presenting primary dysmenorrhea with or without any of the following symptoms associated with- Any kind of pain like headache, backache, abdominal pain, body ache, Nausea and vomiting, Weakness.
3. Psychological symptoms- like anxiety, stress, depression, irritability, restlessness.
4. Willing to participate in the trial.
5. Readiness to sign an informed consent form.
|
|
| ExclusionCriteria |
| Details |
1. Patients having congenital anomalies, patient is suffering from acute infections, cervical stenosis etc.
2. Patients with chronic illness, patient using an intrauterine contraceptive device, and patient with menorrhagia or any uterine pathology (fibroid, adenomyosis, endometriosis etc.) will be excluded from the study.
3. Lactating female.
4. Individuals participating in any other clinical trial.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes pain (Primary dysmenorrhea). |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in associated symptoms |
90 days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/01/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
CLINICAL EVALUATION OF SUNDARI JEEVAK SYRUP IN THE MANAGEMENT OF KASHTARTAVA (PRIMARY DYSMENORRHEA) Research Article ISSN 2455-3301,wjpmr, 2021,7(10), 220 – 229 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is an open labeled, single armed, single center, prospective, interventional clinical study to evaluate the efficacy of the Sundari Jeevak syrup on 50 patients suffering from Kashtartava (Primary dysmenorrhea). The study will be conducted in Panchakarma department, NIA, Jaipur, Rajasthan. It will be advised to subjects to Sundari Jeevak syrup will be given, 14 days after menstruation till the commencement of next cycle for two consecutive cycles. The primary outcome measure will be to assess the efficacy Sundari Jeevak syrup in patients of Kashtartava (Dysmenorrhea) by assessing the Changes pain and duration of pain during menstruation. The secondary outcome will be assess the changes in associated symptoms like nausea, Chhardi, Vibandha, Atisara, Shrama, Aruchi, Shirasula etc |