| CTRI Number |
CTRI/2026/01/100936 [Registered on: 13/01/2026] Trial Registered Prospectively |
| Last Modified On: |
13/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Clinical trial of Dashmoola Vati and Sahacharadi Vati in Sutika Shoola |
|
Scientific Title of Study
|
A Comparative Clinical Study To Evaluate The Efficacy Of Dashmoola Vati And Sahcharadi Vati In Sutika Shoola |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrShubham Ramnath Karle |
| Designation |
MS Scholar Prasuti Tantra Avum Strirog |
| Affiliation |
MAM S Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune |
| Address |
MAM S Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune OPD NO 12 Department Of Prasutitantra Avum Striroga
Pune
MAHARASHTRA
411028
India |
| Phone |
9890810492 |
| Fax |
|
| Email |
shubhamkarle7299@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kalpana Bajrang Ayare |
| Designation |
MS Prasutitantra Avum Striroga |
| Affiliation |
MAM S Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune |
| Address |
MAM S Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune OPD NO 12 Department Of Prasutitantra Avum Striroga
Pune
MAHARASHTRA
411028
India |
| Phone |
9423295630 |
| Fax |
|
| Email |
drkalpanaayare@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kalpana Bajrang Ayare |
| Designation |
MS Prasutitantra Avum Striroga |
| Affiliation |
MAM S Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune |
| Address |
MAM S Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune OPD NO 12 Department Of Prasutitantra Avum Striroga
Pune
MAHARASHTRA
411028
India |
| Phone |
9423295630 |
| Fax |
|
| Email |
drkalpanaayare@gmail.com |
|
|
Source of Monetary or Material Support
|
| MAMS Sumatibhai Shah Ayurveda College Hadapsar Pune 411028 |
|
|
Primary Sponsor
|
| Name |
Dr Shubham Ramnath Karle |
| Address |
MAM S Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune OPD NO 12 Department Of Prasutitantra Avum Striroga |
| 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 Shubham Ramnath Karle |
Sane guruji arogya kendra |
MAM S Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune OPD NO 12 Department Of Prasutitantra Avum Striroga
Hadapsar Pune OPD NO 12 Department of Prasutitantra Avum Striroga
Pune
MAHARASHTRA |
9890810492
shubhamkarle7299@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee MAM S Sumatibhai Shah Ayurved Mahavidyalaya Hadapsar Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O908||Other complications of the puerperium, not elsewhere classified. Ayurveda Condition: SUTIKAROGAH, (2) ICD-10 Condition:O908||Other complications of the puerperium, not elsewhere classified. Ayurveda Condition: SUTIKAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Dashmoola Vati and Sahcharadi Vati, Reference: Bhavprakash chikitsa 70 Yogratnakar , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -koshnajal), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Patient with Full Term Normal Delivery with Sutika-shool will be selected.
Patients from age-group 19 to 40 years of age will be selected.
Patients of any parity will be included |
|
| ExclusionCriteria |
| Details |
Retained placental bits
Uterine rupture
Post-Partum Haemorrhage (Primary and secondary)
Haematoma at episiotomy/Perineal region
Forcep delivery
Ventose delivery
Patient with Tubo-ovarian Mass, Twisted ovaryPatient with known uterine anomaly, Fibroid, etc
Patient with manual removal of Placenta
Patient with known systemic disease, i.e. Diabetes, Renal/Cardiac disease, severe
anaemia, GDM, Immuno-compromised patients etc.
Caesarean Section
Puerperal Tubal Ligation
Sutika taking snehan, swedan and doopan |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evalute the efficacy of Dashmoola vati and sahcharadi vati in sutika shoola in duration of 7 days |
To evalute the efficacy of Dashmoola vati and sahcharadi vati in sutika shoola in duration of 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
20/01/2026 |
| 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="5"
Days="15" |
|
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
|
In present era, the world is giving more attention to lactating mother and her child world health organisation announcing day by day new programmes to promote the health of lactating mothers and her child. Sutika kala is the period following child birth during which all body tissue reverts back to prepregnant state . Most of the changes lead to APATARAPAN of mother during sutika kala which causes VATARUDHI results into sutika shool so it is important to manage her pain during sutika kala. |