| CTRI Number |
CTRI/2023/06/054477 [Registered on: 27/06/2023] Trial Registered Prospectively |
| Last Modified On: |
24/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
CLINICAL STUDY TO ENHANCE THE BREAST MILK BY USING MAGDHYADI YOG IN LACTATING WOMEN. |
|
Scientific Title of Study
|
A single arm clinical study to evaluate the efficacy of Magdhyadi Yog in the management of stanyakshaya ( Lactational insufficiency ) in sutika ( Lactating women ). |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manasi Gaikwad |
| Designation |
Pg scholar |
| Affiliation |
Dr DY Patil College of Ayurved and Research Centre, Pimpri, Pune, 18 |
| Address |
opd no.2 on Ground floor and IPD no.1 on 1st floor of Prasuti Tantra and Streerog department, Dr DY Patil College of Ayurved and Research Centre, Pimpri, Pune, 18
Pune
MAHARASHTRA
411018
India |
| Phone |
7020497547 |
| Fax |
|
| Email |
manasigaikwad213@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR. HRIDYANATH LAD |
| Designation |
Professor |
| Affiliation |
Dr DY Patil College of Ayurved and Research Centre, Pimpri, Pune 18 |
| Address |
Opd no.2 on Ground floor and IPD no.1 on 1st floor of Prasuti Tantra and Streerog department, Dr DY Patil College of Ayurved and Research Centre, Pimpri, Pune, 18
Pune
MAHARASHTRA
411018
India |
| Phone |
9822964454 |
| Fax |
|
| Email |
hridyanath.lad@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hridyanath Lad |
| Designation |
Professor |
| Affiliation |
Dr DY Patil College of Ayurved and Research Centre, Pimpri, Pune 18 |
| Address |
opd no.2 on Ground floor and IPD no.1 on 1st floor of Prasuti Tantra and Streerog department, Dr DY Patil College of Ayurved and Research Centre, Pimpri, Pune, 18
Pune
MAHARASHTRA
411018
India |
| Phone |
9822964454 |
| Fax |
|
| Email |
hridyanath.lad@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR DY PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI PUNE 18 |
|
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Primary Sponsor
|
| Name |
Dr Manasi Gaikwad |
| Address |
opd no.2 on Ground floor and IPD no.1 on 1st floor of Prasuti Tantra and Streerog department, Dr DY Patil College of Ayurved and Research Centre, Pimpri, Pune, 18 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Manasi Gaikwad |
Dr. D Y Patil College of Ayurved and Research Centre , Pimpri Pune |
opd no.2 on Ground floor and IPD no.1 on 1st floor of Prasuti Tantra and Streerog department
Pune
MAHARASHTRA |
7020497547
manasigaikwad213@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O94||Sequelae of complication of pregnancy, childbirth, and the puerperium. Ayurveda Condition: STANYAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: MAGDHYADI YOGA, Reference: HARIT SAMHITA TRITYA STHANA 53/3,4, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 5 Days, anupAna/sahapAna: Yes(details: -GUDA, GOGRITA, GODUGDHA), Additional Information: -GUDA-EQUAL AMOUNT OF CHURNA, GOGRITA 2X OF CHURNA, GODUGDHA 4X OF CHURNA |
|
|
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Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. SUTIKA (POSTNATAL FTND OR LSCS) SUFFERING FROM STANYAKSHAYA.
2. IN ALL PRIMI AND MULTIGRAVIDA.
3. PATIENTS FROM 3RD DAY OF DELIVERY TILL 6 MONTHS AFTER DELIVERY. |
|
| ExclusionCriteria |
| Details |
1. PATIENTS HAVING ANY PATHOLOGICAL CONDITION LIKE ANAEMIA, CONGENITAL ANOMALIES, MALIGNANCY, IMMUNOCOMPROMISED DISORDERS.
2. ANY CHRONIC ILLNESS LIKE HYPERTENSION, DIABETES MELLITUS.
3. PATIENTS HAVING CRACKED NIPPLES, RETRACTED NIPPLES, BREAST ABSCESS, BREAST ENGORGEMENT.
4. BABY WITH CONGENITAL ANOMALIES OR ANY OTHER BIRTH TRAUMA, CLEFT LIP, CLEFT PALATE. |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the efficacy of Magdhyadi yog in the management of stanyakshaya (Lactational
insufficiency) in sutika (Lactating women) From 1 July TO FURTHER 18 MONTHS. |
MAGDHYADI YOG( PIPPALI , SHUNTHI AND HARITAKI CHURNA WITH GOGHRITA,GODUGDHA,GUDA) WILL BE GIVEN ON 0TH UPTO 6 DAYS DAILY. FOLLOW UP WILL BE TAKEN ON 3RD AND 6TH DAY. ASSESTMENT ON OTH AND 6TH DAY. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO OBSERVE ADVERSE EFFECTS OF MAGDHYADI YOG IN MANAGEMENT OF STANYAKSHAYA ( LACTATIONAL INSUFFICIENCY) IN SUTIKA (LACTATING WOMEN). |
MAGDHYADI YOG( PIPPALI , SHUNTHI AND HARITAKI CHURNA WITH GOGHRITA,GODUGDHA,GUDA) WILL BE GIVEN ON 0TH UPTO 6 DAYS DAILY. FOLLOW UP WILL BE TAKEN ON 3RD AND 6TH DAY. ASSESTMENT ON OTH AND 6TH DAY. |
|
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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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
11/07/2023 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
“A SINGLE ARM CLINICAL STUDY TO EVALUATE THE EFFICACY OF MAGDHYADI YOG IN THE MANAGEMENT OF STANYAKSHYA
(LACTATIONAL INSUFFICIENCY) IN SUTIKA (LACTATING WOMEN)’’ THIS TRAIL WILL BE CARRIED OUT ON 30 PATIENTS FULFILLING THE INCLUSION CRITERIA WITH MAGDHYADI YOG 5GM BD WITH ANUPANA OF GUDA EQUAL AMOUNT, 2X GOGRITA AND 4X GODUGDHA FOR 7DAYS. FOLLOW UP WILL BE ON 3RD AND 6TH DAY, ASSESSMENT WILL BE ON 0TH AND 6TH DAY. TOTAL DURATION OF STUDY WILL BE 7 DAYS. |