| CTRI Number |
CTRI/2024/09/073611 [Registered on: 09/09/2024] Trial Registered Prospectively |
| Last Modified On: |
22/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
It is a clinical trial to study the effect of Brahmighrita in the patients suffering from Prementrual Syndrome. |
|
Scientific Title of Study
|
Single arm clinical trial to evaluate the efficacy of Brahmighrita in Premenstrual Syndrome. |
| 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. Bhandwalkar Priyanka Annasaheb |
| Designation |
PG Scholar |
| Affiliation |
Alvas Ayurveda Medical College And Hospital Moodubidire |
| Address |
Department of P.G Studies in Prasuti Tantra Evam Stri Roga,
Alvas Ayurveda Medical College and Hospital
Moodubidre
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
7066379079 |
| Fax |
|
| Email |
priyankabhandwalkar28@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sumarani Rajesh |
| Designation |
Associate Professor |
| Affiliation |
Alvas Ayurveda Medical College and Hospital |
| Address |
Department Of P.G Studies in Prasuti Tantra Evam Stri Roga,
Alvas Ayurveda Medical College and Hospital
Moodubidre
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9449664617 |
| Fax |
|
| Email |
drsumaranirajesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhandwalkar Priyanka Annasaheb |
| Designation |
PG Scholar |
| Affiliation |
Alvas Ayurveda Medical college and Hospital |
| Address |
Department Of P.G Studies in Prasuti Tantra Evam Stri Roga,
Alvas Ayurveda Medical College and Hospital
Moodubidre
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
7066379079 |
| Fax |
|
| Email |
priyankabhandwalkar28@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alvas Ayurveda Medical College and Hospital
Moodubidire, Dakshina Kannada, Karnataka
|
|
|
Primary Sponsor
|
| Name |
Dr Bhandwalkar Priyanka Annasaheb |
| Address |
P.G Scholar
Department Of P.G Studies in Prasuti Tantra Evam Stri Roga,
Alvas Ayurveda Medical College and Hospital
Moodubidre,Dakshina Kannada, Karnataka -574227
|
| 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 Bhandwalkar Priyanka Annasaheb |
Alvas Ayurveda Medical College and Hospital |
Department of P.G Studies in Prasuti Tantra Evam Stri Roga,
Alvas Ayurveda Medical College and Hospital Moodubidire
Dakshina Kannada
KARNATAKA |
7066379079
priyankabhandwalkar28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Alvas Ayurveda Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N943||Premenstrual tension syndrome. Ayurveda Condition: PMS , |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: BRAHMIGHRITA, Reference: Ashtanga Hridaya Uttara Tantra Unmad Chapter , Route: Oral, Dosage Form: Ghrita, Dose: 15(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -SUKHOSHNAJALA), Additional Information: From 7th day prior to menstrual cycle until patient got menses, for 2 consecutive cycle and followup in third cycle |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1) Patients fulfilling diagnostic criteria
2) Women in age group of 16-40 years not using any hormonal contraceptives.
3) Woman having regular menstrual cycle.
|
|
| ExclusionCriteria |
| Details |
1) Patient with diagnosed case of psychiatric disorder i.e neurodevelopment disorder, schizophrenia etc.
2) Patient diagnosed with any pelvic pathology like endometriosis, inflammatory disease.
3) Systemic disorders like Chronic renal diseases, Cardiac disorders, Tuberculosis, Hypertension, Diabetes, Thyroid dysfunctions.
4) Patients with Premenstrual dysphoric disorder.
5) Females using oral contraceptives pills, IUCD, injectable contraceptives.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The effect of treatment is assessed on the basis of
a) Subjective Criteria –
Symptoms appear during 7 days prior to menstrual cycle
b) Objective Criteria-
Symptomatic analysis based on PMS scale screening
|
Treatment duration is given for 2 menstrual cycle and follow-up is taken in third menstrual cycle |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The effect of treatment is assessed on the basis of
a) Subjective Criteria –
Symptoms appear during 7 days prior to menstrual cycle
b) Objective Criteria-
Symptomatic analysis based on PMS scale screening
|
Treatment duration is given for 2 menstrual cycle and follow-up is taken in third menstrual cycle |
|
|
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 3 |
|
Date of First Enrollment (India)
|
01/10/2024 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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)?
|
|
Brief Summary
|
Premenstrual syndrome or PMS is psycho-neuro-endocrine disorder consisting of constellation of mood and behavioral or physical symptoms that have regular clinical relationship to the luteal phase of menstrual cycle. Symptoms includes anger outburst, anxiety, confusion, irritability, abdominal bloating, breast tenderness, headache, joint pain etc. Serotonin and GABA neurotransmitters in the luteal phase may be responsible for the symptom complex. Luteal phase can be considered as Rituvyatitakala as per ayurveda. PMS does not have any direct co-relation in Ayurveda but can be considered as a Tridosha disorder with Pitta dominance and Vata Sanchayaavastha. Brahmi ghrita is chosen for treatment of PMS as it has Medhya, Rasayana, Balya properties. Brahmi ghrita has been indicated for Vandhya which shows its effect on proper functioning of HPO axis. Chemical constituents of Brahmi i.e Brahmine, Monnierin acts on neurotransmitter, dopamine & GABA receptor. Sunthi also known as Vishwabhaishaja relieves all type of pain including colicky pain, joint pain, headache and menstrual Pain. All these qualities of Brahmighrita makes it suitable choice for treatment. therefore, an attempt is made to study the clinical evaluation of Brahmighrita in the management of Premenstrual Syndrome. |