| CTRI Number |
CTRI/2025/07/091391 [Registered on: 22/07/2025] Trial Registered Prospectively |
| Last Modified On: |
21/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparison clinical trial on the effect of two kwath - devdarvyadi kwath and dashmoolaristh in peurperium |
|
Scientific Title of Study
|
A comparative clinic study of efficacy of devdarvyadi kwath and dashmoolaristh in sutika paricharya w s r to peurperium period |
| 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 Ankita Thakur |
| Designation |
PG Scholar |
| Affiliation |
Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal |
| Address |
Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal
Bhopal
MADHYA PRADESH
462044
India |
| Phone |
9144904021 |
| Fax |
|
| Email |
ankitasodaa98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Reetu Pandey |
| Designation |
Associate Professor In Prasooti Tantra Evum Stree Rog |
| Affiliation |
Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal |
| Address |
Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal
Bhopal
MADHYA PRADESH
462044
India |
| Phone |
9805150593 |
| Fax |
|
| Email |
Vdreetupandey@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ankita Thakur |
| Designation |
PG Scholar |
| Affiliation |
Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal |
| Address |
Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal
Bhopal
MADHYA PRADESH
462044
India |
| Phone |
9144904021 |
| Fax |
|
| Email |
ankitasodaa98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rani dullaiya ayurved P.G. college & hospital , bhopal , m.p. , india , 462003 |
|
|
Primary Sponsor
|
| Name |
DR ANKITA THAKUR |
| Address |
P.G. Scholar prasuti tantra evam stri roga , Rani dullaiya ayurved P.G. college & hospital , bhopal , m.p. , india , 462003 |
| 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 ANKITA THAKUR |
Rani dullaiya smriti ayurveda hospital,bhopal |
O P.D. No. 8 , Department of Prasuti tantra evam stri roga,Rani dullaiya smriti ayurveda college and hospital, Bhopal, Madhya Pradesh,
Bhopal
MADHYA PRADESH |
9144904021
ankitasodaa98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Rani Dullaiya Smriti Ayurved PG College And Hospital Bhopal MP |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Sutika paricharya |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dashmoolarishtha, Reference: Sharangdhar Madhyam Khand 10/77-92, Route: Oral, Dosage Form: Arishta, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Devdarvyadi Kwath, Reference: Bhavprakash chi. 70, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Females Reproductive Age
Primi para/multipara
Women in 0 to 10 postpartum days
Women willing and able to participate in the study |
|
| ExclusionCriteria |
| Details |
Women after 11th postpartum day
Puerperium associated with complications like acute inversions of uterus psychosis |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessed for the efficacy of devdaryadi kwath in sutika paricharya |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| managing general health of sutika |
60 days |
|
|
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)
|
01/08/2025 |
| 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="0"
Months="10"
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
|
this is adouble group, open label , comparartive clinical study on the efficacy of devdarvyadi kwath & dashmoolaristh in sutika paricharya w.s.r. to peurperium period . The primary outcome of the study will be to assess efficacy of devdaryadi kwath in managing general health of sutika .and its efficacy will be assesed by subjective and objective criteria . |