| CTRI Number |
CTRI/2024/12/078720 [Registered on: 30/12/2024] Trial Registered Prospectively |
| Last Modified On: |
30/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Gambhari ghanavati in premenstrual syndrome |
|
Scientific Title of Study
|
RANDOMISED OPEN CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF GAMBHARI GHANAVATI TO REDUCE SYMPTOMS OF PITTAVRUTTA VYANA VAYU W.S.R. TO 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 |
Akanksha chandraprakash lokhande |
| Designation |
Pg scholar ,Pre Ms stree roga and prasuti tantra |
| Affiliation |
Yashwant ayurvedic college and research centre, kodoli |
| Address |
Yashwant ayurvedic college and research centre, stree roga and prasuti tantra department OPD no 8 and 15 IPD no 26 ,kodoli district Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9588650308 |
| Fax |
|
| Email |
akankshalokhande10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Akanksha chandraprakash lokhande |
| Designation |
Pg scholar ,Pre Ms stree roga and prasuti tantra |
| Affiliation |
Yashwant ayurvedic college and research centre, kodoli |
| Address |
Yashwant ayurvedic college and research centre, stree roga and prasuti tantra department OPD no 8 and 15 IPD no 26 ,kodoli district Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9588650308 |
| Fax |
|
| Email |
akankshalokhande10@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vishala Turlapati |
| Designation |
PG Guide, professor Striroga and prasuti tantra department |
| Affiliation |
Yashwant ayurvedic college and research centre, kodoli |
| Address |
Yashwant ayurvedic college and research centre, stree roga and prasuti tantra department OPD no 8 and 15 IPD no 26 ,kodoli district Kolhapur
Kolhapur
MAHARASHTRA
416115
India |
| Phone |
9960217429 |
| Fax |
|
| Email |
vishalaturlapati@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant ayurvedic college, kodoli kolhapur 416114 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Akanksha chandraprakash lokhande |
| Address |
Yashwant ayurvedic college and research centre, kodoli district Kolhapur 416114 Maharashtra India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Nil |
Nil |
| Nil |
Nil |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrAkanksha lokhande |
Yashwant ayurvedic college and research centre, kodoli |
OPD no. 8 and 15 stree roga and prasuti tantra
Kolhapur
MAHARASHTRA |
9588650308
akankshalokhande10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BORS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E348||Other specified endocrine disorders. Ayurveda Condition: AVRUTA-VATAH/AVARANAVATA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Pyridoxine | Pyridoxine 100 mg twice daily orally with water every day for 3 menstrual cycle | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Gambhari ghanavati , Reference: Bhavaprakash nighantu/ guduchyadi varga , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -ushnodaka), Additional Information: Dose of gambhari ghanavati 1 gm in 4 divided doses of two tablets of 250mg twice daily orally with water for 3 menstrual cycles |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1)patient fulfilling diagnostic criteria of pittavritta vyana vayu based on symptoms
2) patient are selected of age group between 18-35
3) Regular menstruating females
4) patient having BMI between 18-28 |
|
| ExclusionCriteria |
| Details |
1)K/H/O mood disturbance because of any systemic disorder or any other psychiatric disorder and patients on antipsychotic drugs
2)Women with K/H/O severe systemic illness
3)Women who taking oral contraceptive and hormone replacement therapy
4) Major gynaecological disorders
5) pregnant females
6) Patients having BMI more than 28 |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To reduce physical, emotional and behavioral symptoms before or in menses |
To see the efficacy of gambhari ghanavati in premenstral syndrome in 90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the etio pathology of pittavritta vyana vayu and premenstrual disorders in detail with classic Ayurveda and modern text along with published data |
To achieve the outcome of study in 120 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
10/01/2025 |
| 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="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
|
Premenstrual syndrome can affect the quality of life of female which may hamper her performance areas for considerably longer period which need to be addressed by an effective herbal preparation.
Ayurvedic line of management of pittavritta vyana vayu is it should be managed with pitta shamak & vaata anulomaka ahar vihar & aushadhis there are many formulations explained in ayurveda having pittashamak Property. Ashwagandha, Shatavari, Bala, Yashtimadhu etc .for treating pittavritta vyan vayu, I have chosen Gambhari which is described in bhavaprakasha
|