| CTRI Number |
CTRI/2024/11/076972 [Registered on: 18/11/2024] Trial Registered Prospectively |
| Last Modified On: |
14/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
to evaluate the effect of Mustadi vati in Stanapeeda with respect to Breast Engorgement in Sutika avastha. |
|
Scientific Title of Study
|
Single arm, open label clinical study to evaluate the effect of Mustadi vati in Stanapeeda with respect to Breast Engorgement in Sutika avastha. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyanka Tekriwal |
| Designation |
MS Scholar |
| Affiliation |
Sumatibhai Shah Ayurved Mahavidyalaya |
| Address |
Prasuti tantra and streerog department, sumatibhai shah ayurved mahavidyalya, Survey No. 165-A, Tupe Patil Rd, Malwadi, Hadapsar, Pune, Maharashtra
Survey No. 165-A, Tupe Patil Rd, Malwadi, Hadapsar, Pune, Maharashtra 411028
Pune
MAHARASHTRA
411028
India |
| Phone |
8169315651 |
| Fax |
|
| Email |
priyankatekriwal98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kalpana B . Ayare |
| Designation |
MS prasuti tantra and streerog |
| Affiliation |
Sumatibhai Shah Ayurved Mahavidyalaya |
| Address |
Prasuti tantra and streerog department, sumatibhai shah ayurved mahavidyalya, Survey No. 165-A, Tupe Patil Rd, Malwadi, Hadapsar, Pune, Maharashtra
Survey No. 165-A, Tupe Patil Rd, Malwadi, Hadapsar, Pune, Maharashtra 411028
Pune
MAHARASHTRA
411028
India |
| Phone |
9423295630 |
| Fax |
|
| Email |
drkalpanaayare@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Priyanka Tekriwal |
| Designation |
MS Scholar |
| Affiliation |
Sumatibhai Shah Ayurved Mahavidyalaya |
| Address |
Prasuti tantra and streerog department, sumatibhai shah ayurved mahavidyalya, Survey No. 165-A, Tupe Patil Rd, Malwadi, Hadapsar, Pune, Maharashtra 411028
Survey No. 165-A, Tupe Patil Rd, Malwadi, Hadapsar, Pune, Maharashtra 411028
Pune
MAHARASHTRA
411028
India |
| Phone |
8169315651 |
| Fax |
|
| Email |
priyankatekriwal98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Prasuti tantra and streerog department, sumatibhai shah ayurved mahavidyalya, Survey No. 165-A, Tupe Patil Rd, Malwadi, Hadapsar, Pune, Maharashtra ,India,411028 |
|
|
Primary Sponsor
|
| Name |
Sumatibhai Shah Ayurved Mahavidyalya |
| Address |
Survey No. 165-A, Tupe Patil Rd, Malwadi, Hadapsar, Pune, Maharashtra 411028 |
| Type of Sponsor |
Private medical college |
|
|
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 Priyanka Tekriwal |
Sumatibhai Shah Ayurved Mahavidyala |
Prasuti tantra and streerog department, sumatibhai shah ayurved mahavidyalya, Survey No. 165-A, Tupe Patil Rd, Malwadi, Hadapsar, Pune, Maharashtra 411028
Pune
MAHARASHTRA |
8169315651
priyankatekriwal98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O922||Other and unspecified disorders ofbreast associated with pregnancy and the puerperium. Ayurveda Condition: STANYAVAHA-SROTODUSHTI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Mustadi vati, Reference: Sushrut, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 5 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Purpureal women after vaginal or caesarean section diagnosed with Stanapeeda with respect to Breast Engorgement. |
|
| ExclusionCriteria |
| Details |
Breast abscess
- Breast wound eg. Crack nipples.
- Breast Fibroadenoma
- Mastitis.
- CA Breast and other skin lesions or disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of Mustadi vati 500mg TDS for consecutive 5days in Stanapeeda with respect to Breast Engorgement. |
For consecutive 5 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of Mustadi vati 500mg TDS for consecutive 5days in Stanapeeda with respect to Breast Engorgement. |
For consecutive 5 days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
15/12/2024 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Breast Engorgement is stated as enlarged and filling of the breasts with milk. It is the physiologic condition characterized by the painful swelling of the breasts associated with sudden increase in milk volume, lymphatic and vascular congestion and interstitial edema during the first two weeks following birth. It is associated with hard, painful, throbbing, aching, and tender breasts which may result in women needing analgesia, developing mastitis which may lead to temporarily or permanently stopping breastfeeding |