| CTRI Number |
CTRI/2025/08/092201 [Registered on: 01/08/2025] Trial Registered Prospectively |
| Last Modified On: |
03/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic
Preventive
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Management of sutika kaal by dashmool kwath and sahacharadi kwath |
|
Scientific Title of Study
|
A Comparative Clinical Study On Effect of Saharachadi Kwath And Dashmool Kwath In sutika Kaal wsr to Sutikavatahar aushadh nishkwathen upcharet |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Muskan Nainwani |
| Designation |
MD Scholar |
| Affiliation |
Pandit Khushilal Sharma Goverment Ayurveda College And Institute Bhopal |
| Address |
Pg Department of Samhita Siddhant Pandit Khushilal Sharma Goverment Ayurveda College And Institute Bhopal
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
8989057412 |
| Fax |
|
| Email |
nainwanimuskan6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pawan kirar |
| Designation |
Assistant Professor |
| Affiliation |
Pandit Khushilal Sharma Goverment Ayurveda College And Institute Bhopal |
| Address |
Pg Department of Samhita Siddhant Pandit Khushilal Sharma Goverment Ayurveda College And Institute Science Hills Behind Manit Bhopal MP India 462003
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9424786559 |
| Fax |
|
| Email |
dr.pawan1980@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Muskan Nainwani |
| Designation |
MD Scholar |
| Affiliation |
Pandit Khushilal Sharma Goverment Ayurveda College And Institute Bhopal |
| Address |
Pg Department of Samhita Siddhant Pandit Khushilal Sharma Goverment Ayurveda College And Institute Bhopal
MADHYA PRADESH
462003
India |
| Phone |
8989057412 |
| Fax |
|
| Email |
nainwanimuskan6@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pandit Khushilal goverment Ayurveda College And Institute Behind Manit Science Hills Bhopal MP India 462003 |
|
|
Primary Sponsor
|
| Name |
Pandit Khushilal Sharma Goverment Ayurveda College And Institute Bhopal |
| Address |
Science Hills Behind Manit Kolar Road Bhopal Mp India 462003 |
| Type of Sponsor |
Government funding agency |
|
|
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 Muskan Nainwani |
Pandit Khushilal Sharma Goverment Ayurveda College And Institute Bhopal |
Room No 231 Pg Department of Samhita Siddhant Science Hills Behind Manit Kolar Road Bhopal MP
Bhopal
MADHYA PRADESH |
8989057412
nainwanimuskan6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committe Pt Khushilal Sharma Govt Ayurveda College And Institute Bhopal MP |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O268||Other specified pregnancy relatedconditions. Ayurveda Condition: SUTIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Sahacharadi Kwath and Dashmool Kwath, Reference: Chakradatta , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Post natal women of age 20 to 40 years
Post natal women after NVD with fever fatigue backache pedal oedema
constipation urine disorder |
|
| ExclusionCriteria |
| Details |
Women with a delivery by any surgical procedure
Women with bad obstetric history
Women with any preexisting venereal diseases
Women having any systemic disorder like hypertension diabetes mellitus
ischemic heart disease malignancy or any acute infection
Postpartum females with malignancy and eclampsia
Post partum hemorrhage Retained placenta |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
By virtue of Ras panchak Sahacharadi Kwath and Dashmool Kwath by tridhosh shamak
especially Vaat Shamak Deepan,Pachana,Vaatanuloman cures vitiated Vaatdosha in Sutika.
It is expected that at the end of the study we would be able to evaluate the efficacy of
Sahacharadi Kwath and Dashmool Kwath |
It is Expected there will be significant result within forty five days of this trial |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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="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
|
According to Acharyas at this stage Prakop of Vaat occurs So Acharyas have given definite duration of specific regimen for management of puerperal woman for that there are many types of Kwath Mentioned Acharya Chakradutt has mentioned Sahacharadi Kwath and Dashmool Kwath for Sutika Kaal There are various types of Ayurvedic formulations like Kwath Asava Arishta Taila Ghrita Avleha etc Kwath is one of the most used dosage forms among all primary pharmaceutical preparation of Ayurvedic pharmaceutics with a wide range of therapeutic usage Kwath is the potent therapeutic preparation of liquid form containing water soluble constituents responsible for therapeutic activity So here we use Kwath preparations for puerperal period study In Dashmoola contains ten roots of different ten plants which are taken in equal proportion Generally it is considered as a combination of Brihat Panchamoola and Laghu Panchamoola The combination of these ten roots is used widely in Ayurveda which acts on Vata Dosha and reduces its aggravation Similarly Sahacharadi kwath by virtue of Ras panchak acts on vitation of Vaat So here in this study evaluation of Sahacharadi kwath and Dashmool Kwath in Sutika Kaal is to be done It is essential to improving maternal outcomes and to continue reducing maternal mortality and morbidity rate Hence this study has been taken which will help to reduce post natal maternal mortality and morbidity along with enhancing puerperal quality life which will also be cost effective and feasible to use |