| CTRI Number |
CTRI/2024/05/067335 [Registered on: 14/05/2024] Trial Registered Prospectively |
| Last Modified On: |
23/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Therapeutic] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Kashtartava (Primary Dysmenorrhoea) - Ayurvedic management with Shatavari Taila Matrabasti and Tila Taila Matrabasti |
|
Scientific Title of Study
|
A Randomized Controlled Trial to evaluate the efficacy of Shatavari Taila Matrabasti in the management of Kashtartava 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 |
Dr Preeti Kshitij Jadhav |
| Designation |
PhD Scholar |
| Affiliation |
Government Ayurved College and Hospital , Nagpur |
| Address |
Government Ayurved College, Department of Prasutitantra-Streerog, 2nd Floor,
Raje Raghuji Nagar,
Umred Road, Sakkardara, Nagpur
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9422210229 |
| Fax |
|
| Email |
dr.preetikjadhav@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manoj V Gaikwad |
| Designation |
Professor & HOD ( PhD Guide) |
| Affiliation |
R.A. Podar Ayurved Medical College and Hospital |
| Address |
R.A. Podar Ayurved Medical College,
Department of Prasutitantra and Streerog, Annie Besant Road, Worli, Mumbai
Mumbai
MAHARASHTRA
400018
India |
| Phone |
9822752816 |
| Fax |
|
| Email |
drmanojvgaikwad@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Preeti Kshitij Jadhav |
| Designation |
PhD Scholar |
| Affiliation |
Government Ayurved College and Hospital , Nagpur |
| Address |
Government Ayurved College, Department of Prasutitantra-Streerog, 2nd Floor,
Raje Raghuji Nagar,
Umred Road, Sakkardara, Nagpur
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9422210229 |
| Fax |
|
| Email |
dr.preetikjadhav@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurved College and Hospital, Nagpur |
|
|
Primary Sponsor
|
| Name |
Dr Preeti Kshitij Jadhav |
| Address |
Government Ayurved College and Hospital, Raje Raghuji Nagar, Umred Road, Sakkardara, Nagpur 440024 |
| 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 Preeti Kshitij Jadhav |
Government Ayurved College and Hospital, Nagpur |
OPD No. 42, Department of Prasutitantra and Streeroga, Raje Raghuji Nagar,Umred Road, Sakkardara, Nagpur 440024
Nagpur
MAHARASHTRA |
9422210229
dr.preetikjadhav@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, Government Ayurved College,Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N944||Primary dysmenorrhea. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | mAtrAbastiH, मातà¥à¤°à¤¾à¤¬à¤¸à¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Charak Samhita, Procedure details: Tila Taila Matrabasti 60 ml Once a day for 7 days before commencement of menses for 3 menstrual cycles)
(1) Medicine Name: Tila Taila , Reference: Bhavprakash Nighantu, Taila varga, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 7 Days | | 2 | Intervention Arm | Procedure | - | mAtrAbastiH, मातà¥à¤°à¤¾à¤¬à¤¸à¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Charak Samhita, Procedure details: Shatavari Taila Matrabasti 60 ml Once a day for 7 days before commencement of menses for 3 menstrual cycles)
(1) Medicine Name: Shatavari Taila, Reference: Kashyap Samhita, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
24.00 Year(s) |
| Gender |
Female |
| Details |
1. Patients coming with complaint of painful
menses.
2. Adolescent girls of age between 18 to 24 years.
3. Patients suffering from Kashtartava for at
least 3 consecutive regular menstrual cycles.
4. Patient who agrees to participate and is ready
to sign the informed consent form.
|
|
| ExclusionCriteria |
| Details |
1. Patients below 18 years and above 24 years.
2. Married women.
3. Patients of Secondary dysmenorrhoea.
4. Patients having congenital anomaly of
reproductive tract like hypoplastic uterus.
5. Patients having organic pathology of uterus and
adnexa like fibroid uterus, carcinoma of
endometrium.
6. Patients with Dysfunctional uterine bleeding,
Pelvic Inflammatory diseases, Endometritis.
7. Patients having conditions where surgical
intervention should be needed.
8.Patients with systemic diseases.
9.Patients taking hormonal therapy.
10.Patient who is not willing to give informed
consent.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Shatavari Taila Matrabasti in the management of Kashtartava with special reference to Primary Dysmenorrhea on VAS scale |
before treatment (on day 1 and day 5)and after treatment (on day 1 and day 5) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effect of Shatavari Taila Matrabasti on reduction in intensity & duration of pain present in Kashtartava with special referance to Primary Dysmenorrhea |
before treatment (on day 1 & day 5)and after treatment (on day 1 & day 5) |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
01/06/2024 |
| 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="3"
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 study is randomized, parallel group, open labelled, controlled
clinical trial to evaluate and compare the efficacy of Shatavari Taila
Matrabasti and Tila Taila Matrabasti in Kashtartava with special
referance to Primary Dysmenorrhea. Study Population- Adolescent girls of
age 18-24 years having symptoms of Kashtartava.120 patients
of Kashtartava from OPD, IPD and Casualty of Govt. Ayurved Hospital,
Nagpur
will be taken. They will be divided into two groups by the random
number table method.
The trial group will be administered Shatavari Taila Matrabasti 60 ml
once a day for 7 days before commencement of menses for 3 consecutive
menstrual cycles and
the
comparison group will be administered Tila Taila Matrabasti 60 ml once a
day before commencement of menses for 3 consecutive menstrual cycles.
Comparison of the effects on the subjective
parameters before and after treatment between two groups will be done.
Follow-ups will be done. The results will be analyzed statistically to
draw conclusions from the study.
|