| CTRI Number |
CTRI/2020/12/029731 [Registered on: 11/12/2020] Trial Registered Prospectively |
| Last Modified On: |
09/12/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of saptachakra ghanavati in the treatment of pain during menstruation. |
|
Scientific Title of Study
|
A randomized open labelled control clinical trial to evaluate the efficacy of saptachakra ghanavati in the management of Spasmodic dysmenorrhea |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vasanthi Thondambatti |
| Designation |
Assistant Professor |
| Affiliation |
Parul Institute of Ayurved and Research |
| Address |
Department of Prasooti tantra and streeroga
Parul Institute of Ayurved and Research
Ishwarapura
PO: limda
Waghodia, Vadodara
house no: 32/A
Akshar Yug society
Opposite Gayitri mandir
Waghodia road
Vadodra
Vadodara
GUJARAT
391760
India |
| Phone |
9490887152 |
| Fax |
0 |
| Email |
dr.vasanthi.bams@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vasanthi Thondambatti |
| Designation |
Assistant Professor |
| Affiliation |
Parul Institute of Ayurved and Research |
| Address |
Department of Prasooti tantra and streeroga
Parul Institute of Ayurved and Research
Ishwarapura
PO: limda
Waghodia, Vadodara
house no: 32/A
Akshar Yug society
Opposite Gayitri mandir
Waghodia road
Vadodra
Vadodara
GUJARAT
391760
India |
| Phone |
9490887152 |
| Fax |
0 |
| Email |
dr.vasanthi.bams@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vasanthi Thondambatti |
| Designation |
Assistant Professor |
| Affiliation |
Parul Institute of Ayurved and Research |
| Address |
Department of Prasooti tantra and streeroga
Parul Institute of Ayurved and Research
Ishwarapura
PO: limda
Waghodia, Vadodara
house no: 32/A
Akshar Yug society
Opposite Gayitri mandir
Waghodia road
Vadodra
Vadodara
GUJARAT
391760
India |
| Phone |
9490887152 |
| Fax |
0 |
| Email |
dr.vasanthi.bams@gmail.com |
|
|
Source of Monetary or Material Support
|
| Center of research for development |
|
|
Primary Sponsor
|
| Name |
Center of Research for Development |
| Address |
Parul University
Limda
Waghodia, Vadodara |
| Type of Sponsor |
Other [Research Cell of private University] |
|
|
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 Vasanthi Thondambatti |
khemdas ayurved Hospital |
Department of Prasooti tantra nad streeroga
OPD NO: 05
Parul institute of Ayurved and Research
Ishwarapura
Limda
Waghodia
Vadodara
GUJARAT |
9490887152
0
dr.vasanthi.bams@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PIARIECHR |
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 |
Rajapravartini Vati |
250mg Three time a day after food with water |
| Intervention |
Saptachakra ghana vati |
500mg two times a day after food with luke warm water |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
1. Unmarried women, with regular cycle who complaint of painful menstruation,
2. without pelvic pathology
|
|
| ExclusionCriteria |
| Details |
1. PID, endometriosis and debilitating pathological conditions of the pelvic organs ,
Women Suffering from systemic diseases, with organic lesion (benign or malignant growth of reproductive tract), any degree of prolapsed and Hypoplastic uterus,
2.Polycystic ovarian disease (pcod), any congenital abnormality of genital organs
3.Married women and irregular cycles
4.The age beyond the 25years.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Relief from pain
facilitation of normal menstrual flow |
The patients are fallowed in the interval of 7days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| regulerising meneses without complications. |
outcomes regularly monitored every 1 month for the period of 3 months |
|
|
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 1 |
|
Date of First Enrollment (India)
|
21/12/2020 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Publication is not yet completed |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Dysmenorrhea
means painful menstruation which can be correlated with udavartini yonivyapad of charaka or Udavarta of sushruta. It occurs
in 50% of post-pubescent females.Spasmodic dysmenorrhea is an important
clinical as well as social problem affecting more than 50% of menstruating
women. Though the modern medicine has made an unbelievable progress in
understanding “dysmenorrheaâ€, no new progress has been made in the line of
management. Moreover, the principal drugs i.e. NSAID’S used have many side
effects in sensitive individuals, which restrict their use.Therefore, a complete,
comprehensive and holistic approach toward its understanding and treatment is
the need of the age. An attempt has been made here to treat this condition with
drug mentioned in classics |