| CTRI Number |
CTRI/2024/12/078327 [Registered on: 19/12/2024] Trial Registered Prospectively |
| Last Modified On: |
17/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
TO STUDY THE EFFECT OF DRAKSHA AVALEHA IN 2nd TRIMESTER OF PREGNANCY THE MANAGEMENT OF GARBHINI PANDU |
|
Scientific Title of Study
|
A CLINICAL STUDY TO EVALUATE THE EFFICACY OF DRAKSHA AVALEHA IN THE MANAGEMENT OF GARBHINI PANDU |
| 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 Sejal Bedmutha |
| Designation |
PG scholar |
| Affiliation |
Seth Sakharam Nemchand Jain Ayurved Rugnalaya |
| Address |
OPD NO 4 PRASUTITANTRA EVUM STREEROG DEPT,SETH SAKHARAM NEMCHAND JAIN AYURVED RUGNALAYA 118/119 SHUKRAWAR PETH,NEAR JUNI FAUJDAR CHAWDI SOLAPUR 413002 MAHARASHTRA INDIA
Solapur
MAHARASHTRA
413002
India |
| Phone |
7020626747 |
| Fax |
|
| Email |
sejalbedmutha424@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Veena Jawale |
| Designation |
HOD SRPT |
| Affiliation |
Seth Sakharam Nemchand Jain Ayurved Rugnalaya solapur |
| Address |
OPD NO 4 PRASUTITANTRA EVUM STREEROG DEPT,SETH SAKHARAM NEMCHAND JAIN AYURVED RUGNALAYA, 118/119 SHUKRAWAR PETH, NEAR JUNI FAUJDAR CHAWDI, SOLAPUR 413002 MAHARASHTRA INDIA
Solapur
MAHARASHTRA
413002
India |
| Phone |
9028244410 |
| Fax |
|
| Email |
veena.jawale@sgrayurved.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sejal Bedmutha |
| Designation |
PG Scholar |
| Affiliation |
Seth Sakharam Nemchand Jain Ayurved Rugnalaya Solapur |
| Address |
OPD NO 4 PRASUTITANTRA EVUM STREEROG DEPT,SETH SAKHARAM NEMCHAND JAIN AYURVED RUGNALAYA, 118/119 SHUKRAWAR PETH, NEAR JUNI FAUJDAR CHAWDI, SOLAPUR 413002 MAHARASHTRA INDIA
Solapur
MAHARASHTRA
413002
India |
| Phone |
7020626747 |
| Fax |
|
| Email |
sejalbedmutha424@gmail.com |
|
|
Source of Monetary or Material Support
|
| Seth Sakharam Nemchand Jain Ayurveda Rugnalaya, 118/119 shukrawar peth, near juni faujdar
chawdi, solapur, MAHARASHTRA 413002 India |
|
|
Primary Sponsor
|
| Name |
Dr Sejal Bedmutha |
| Address |
Seth Sakharam Nemchand Jain Ayurveda Rugnalaya, 118/119
shukrawar peth, near juni faujdar chawdi, solapur, MAHARASHTRA
413002 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 Sejal Bedmutha |
Seth Sakharam Nemchand Jain Ayurveda Rugnalaya |
OPD No 4, PRASUTITANTRA EVUM STREEROG DEPT,Seth Sakharam Nemchand Jain Ayurveda Rugnalaya, 118/119 shukrawar peth,near juni faujdar
chawdi,solapur,MAHARASHTRA 413002 India
Solapur
MAHARASHTRA |
7020626747
sejalbedmutha424@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:O251||Malnutrition in pregnancy. Ayurveda Condition: GARBINIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Draksha Avaleha, Reference: Ashtanghridaya chikitsasthan 16/29-31, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Dugdha), Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
2nd trimester of pregnancy
Subject fulfilling diagnostic criteria of HB HCT MCV |
|
| ExclusionCriteria |
| Details |
1st and 3rd trimester of pregnancy
Hb below 8 gm/dl
High risk patient like PIH GDM
Seropositive Patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO EVALUATE THE EFFICACY OF DRAKSHA AVALEHA IN THE MANAGEMENT OF GARBHINI PANDU |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the disease Garbhini Pandu |
1 year 6 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
28/12/2024 |
| 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
|
In Ayurveda great importance has been given to Garbhini paricharya including pathyaapathya to protect the growing foetus and nourishment for healthy womb.The foetus is completely dependent on its mother for its growth and development during pregnancy the demand of iron much more increased by both mother and foetus. In majority cases the Garbhini Pandu occurs due to deficiency of iron is directly responsible for 20% maternal death .According to WHO prevalence of anaemia in developed and developing country in pregnant women is estimated at about 14% in developed and 51% in developing countries. In India the prevalence is 65 to 75%. WHO defines anemia as presence of hemoglobin less than 11gm/dl.Iron containing drugs are used in modern medicine as a heamataics but these drugs induce some adverse drug reaction like nausea ,vomiting ,metallic test, epigastric pain. Anaemia can be correlated with Pandu explain in Ayurveda classics with all above background,this topic is chosen in the management of Garbhini Pandu. Treatment period will be of 2 months and follow up on 15th 30th 45th and 61th day. |