| CTRI Number |
CTRI/2024/12/078056 [Registered on: 12/12/2024] Trial Registered Prospectively |
| Last Modified On: |
11/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
TO STUDY COMBINED EFFECT OF BRAHMI GHRITA UTTARBASTI WITH ORAL ADMINISTRATION OF PUTRANJEEVAK CHURNA IN THE MANAGEMENT OF VANDHYATVA DUE TO ANOVULATION |
|
Scientific Title of Study
|
A CLINICAL STUDY TO EVALUATE THE COMBINED EFFICACY OF BRAHMI GHRITA UTTARBASTI WITH ORAL ADMINISTRATION OF PUTRANJEEVAK CHURNA IN THE MANAGEMENT OF VANDHYATVA DUE TO ANOVULATION |
| 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 Samiksha Jain |
| Designation |
PG Scholar |
| Affiliation |
Seth govindji Raoji Ayurved mahavidhyalaya , solapur |
| Address |
OPD no 4 prasuti tantra evum streerog department, Seth Sakharam Nemchand Ayurved Rugnalaya 118/119, shukrawar peth, near juni faujdar chawadi, solapur MAHARASHTRA 413002 India
Solapur
MAHARASHTRA
413002
India |
| Phone |
7350144121 |
| Fax |
|
| Email |
jainsamiksha49@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Veena Jawale |
| Designation |
HOD, Prasuti tantra evum streerog department |
| Affiliation |
Seth govindji Raoji Ayurved mahavidhyalaya , solapur |
| Address |
OPD no 4 prasuti tantra evum streerog department, Seth Sakharam Nemchand Ayurved Rugnalaya 118/119, shukrawar peth, near juni faujdar chawadi, solapur MAHARASHTRA 413002 India
OPD no 4 prasuti tantra evum streerog department, Seth Sakharam Nemchand Ayurved Rugnalaya 118/119, shukrawar peth, near juni faujdar chawadi, solapur MAHARASHTRA 413002 India
Solapur
MAHARASHTRA
413003
India |
| Phone |
9028244410 |
| Fax |
|
| Email |
veena.jawale@sgrayurved.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Samiksha Jain |
| Designation |
PG scholar |
| Affiliation |
Seth govindji Raoji Ayurved mahavidhyalaya , solapur |
| Address |
OPD no 4 prasuti tantra evum streerog department, Seth Sakharam Nemchand Ayurved Rugnalaya 118/119, shukrawar peth, near juni faujdar chawadi, solapur MAHARASHTRA 413002 India
Solapur
MAHARASHTRA
413002
India |
| Phone |
07350144121 |
| Fax |
|
| Email |
jainsamiksha49@gmail.com |
|
|
Source of Monetary or Material Support
|
| Seth Sakharam Nemchand Jain Ayurveda Rugnalaya 118/119 shukrawar peth near juni faujdar chawdi Solapur MAHARASHTRAÂ 413002Â India |
|
|
Primary Sponsor
|
| Name |
Dr. Samiksha JAIN |
| Address |
Seth Sakharam Nemchand Jain Ayurveda Rugnalaya 118/119 shukrawar peth near juni faujdar chawdi Solapur MAHARASHTRAÂ 413002Â India |
| 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 Samiksha Jain |
Seth Sakharam Nemchand Ayurved Rugnalaya Solapur |
OPD no 4 prasuti tantra evum streerog department, Seth Sakharam Nemchand Ayurved Rugnalaya 118/119, shukrawar peth, near juni faujdar chawadi, solapur MAHARASHTRA 413002 India
Solapur
MAHARASHTRA |
07350144121
jainsamiksha49@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Seth Sakharam Nemchand Jain Ayurved Rugnalaya solapur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N00-N99||Diseases of the genitourinary system. Ayurveda Condition: VANDHYA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | uttara-bastiH, उतà¥à¤¤à¤°-बसà¥à¤¤à¤¿à¤ƒ | (Procedure Reference: charak siddhi sthana 9/50, Procedure details: 5ml of ghrita administared through genital route from 8th to12th day of menstrution for 3 consecative cycle)
(1) Medicine Name: brahmi ghrita, Reference: ashtang hrudhyam uttarsthan 6/23-25, Route: Vaginal, Dosage Form: Ghrita, Dose: 5(ml), Frequency: od, Duration: 3 Months(2) Medicine Name: putranjeevaka churna, Reference: bhavprakash, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Duration: 3 Months |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Day(s) |
| Age To |
40.00 Day(s) |
| Gender |
Female |
| Details |
married
diagnosed anovulatory cycle
primary and secondary infertility |
|
| ExclusionCriteria |
| Details |
systemic disease like hypertension
diabetes |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| combined efficacy of Brahmi Ghrita Uttarbasti with oral administration of Putranjeevak Churna |
8th to 12 th day of three consicative cycles of mensturation
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
understand the anovulatory cycle
|
3 months
8th to 12th day of menstrual cycle for 3 consecutive cycles
churna for 90 days oral administration |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
23/12/2024 |
| 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="6"
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
|
Reproduction is a blessing that aids in transferring the genes from one generation to another and thus aid to evalution In Ayurveda Acharya Shruta describes four essential factors for healthy pregnancy such as, Ritu, Kshetra, Ambu, Beeja among them Beeja is core stone for conception. the dushti in beeja formation, development and rupture may ba considered as anovulation Anovulation is a cause of infertility. In todays world the infertility is increasing day by day so it is neded to focus on this problem. in India approximately 8.9 percent of currently marrrird women suffer from infertility. in this ayurveda is more effective and affordable. so Brahmi ghrita with oral administration of putranjeevak churna is selected. uttarbasti have an effective role in anovulation, brahmi acts as prajastapan. putranjeevak is garbhadayak and viryavardhak. aal this drugs are work on pathology |