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CTRI Number  CTRI/2025/02/081047 [Registered on: 21/02/2025] Trial Registered Prospectively
Last Modified On: 20/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   An assessment of efficacy of Shatavari kalpa along with Sattvavajaya Chikitsa in the management of Post Partum Depression 
Scientific Title of Study   An assessment of efficacy of Shatavari kalpa along with Sattvavajaya chikitsa in the management of Post Partum Depression: A randomised, open-labeled, comparative clinical trial 
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 Bhavika Dube 
Designation  PG student 
Affiliation  D. Y. Patil deemed to be university school of Ayurveda, Nerul, Navi Mumbai 
Address  OPD No. 4, D. Y. Patil Ayurvedic Hospital and D. Y. Patil deemed to be university school of Ayurveda, Nerul, sector 7, Navi Mumbai

Thane
MAHARASHTRA
401209
India 
Phone  7045180163  
Fax    
Email  bhavikapandey8@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mahesh Kumar Harit 
Designation  Head of Department of Sanskrit Samhita and Siddhant 
Affiliation  D. Y. Patil deemed to be university school of Ayurveda, Nerul, Navi Mumbai 
Address  OPD No. 4, D. Y. Patil Ayurvedic Hospital, D. Y. Patil deemed to be university school of Ayurveda, Nerul, sector 7, Navi Mumbai

Thane
MAHARASHTRA
400706
India 
Phone  9322217607  
Fax    
Email  maheshkumar.harit@dypatil.edu  
 
Details of Contact Person
Public Query  
Name  Dr Mahesh Kumar Harit 
Designation  Head of Department of Sanskrit Samhita and Siddhant 
Affiliation  D. Y. Patil deemed to be university school of Ayurveda, Nerul, Navi Mumbai 
Address  OPD No. 4, D. Y. Patil Ayurvedic Hospital and D. Y. Patil deemed to be university school of Ayurveda, Nerul, sector 7, Navi Mumbai

Thane
MAHARASHTRA
400706
India 
Phone  9322217607  
Fax    
Email  maheshkumar.harit@dypatil.edu  
 
Source of Monetary or Material Support  
Dept of Sanskrit Samhita Siddhant, D. Y. Patil deemed to be university school of Ayurveda, Nerul, sector 7, Navi Mumbai - 400 706. Maharashtra State, India 
 
Primary Sponsor  
Name  Dr Bhavika Dube 
Address  Dept of Sanskrit Samhita Siddhant, D. Y. Patil deemed to be university school of Ayurveda, Nerul, sector 7, Navi Mumbai - 400 706. Maharashtra State, India 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mahesh Kumar Harit  D. Y. Patil deemed to be university school of Ayurveda, Nerul, Navi Mumbai  D. Y. Patil deemed to be university school of Ayurveda, Department of Sanskrit Samhita and Sidhhant, Nerul, sector 7, Navi Mumbai, 400706
Thane
MAHARASHTRA 		 9322217607

maheshkumar.harit@dypatil.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, D. Y. Patil deemed to be University School of Ayurveda, Nerul, Navi Mumbai - 400 706., D. Y. Patil deemed to be University School of Ayurveda, Nerul, Navi Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F078||Other personality and behavioral disorders due to known physiological condition. Ayurveda Condition: VISHADAH/DINATA (KEVALAVATA), (2) ICD-10 Condition:F09||Unspecified mental disorder due toknown physiological condition. Ayurveda Condition: VISHADAH/DINATA (KEVALAVATA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugOther than Classical(1) Medicine Name: shatavari kalpa, Reference: NA, Route: Oral, Dosage Form: Khanda/Granules, Dose: 10(g), Frequency: od, Bhaishajya Kal: Antarabhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: -ushnodak), Additional Information: -Sattvavajaya chiktsa in the form of pranayam and meditation daily for 25 minutes for 4 weeks with ashvasan chikitsa on every follow up and shatavari kalpa 10gms OD orally bhojanuttar with ushnodak for 4 weeks
2Intervention ArmDrugOther than Classical(1) Medicine Name: Shatavari Kalpa, Reference: NA, Route: Oral, Dosage Form: Khanda/Granules, Dose: 10(g), Frequency: od, Bhaishajya Kal: Antarabhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: -ushnodak), Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  onset from 4 weeks to 6 months of postpartum irrespective of gravida

 
 
ExclusionCriteria 
Details  patients already diagnosed with neuropyschological disorders
patients having systemic illness or postpartum haemorrhage 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the effect of shatavari kalpa in the management of post partum depression
To assess the effect of sattvavajaya chikitsa in the management of postpartum depression 		 Day 0, 1st week, 2nd week, 3rd week, 4th week 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the effect of shatavari kalpa with sattvavajaya chikitsa in the management of post partum depression   
 
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)   11/03/2025 
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 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  

Total 60 women within 4 weeks of giving birth upto 6 months’ post-partum in the age group pf 20-35yrs will be screened according to inclusion and exclusion criteria of the study and included in the study after taking written informed consent. They will be explained the whole work that is to be done provided the information of the patient’s to be confidential. Diagnosis of patients will be using EDINBURGH’S POSTNATAL DIAGNOSTIC AND SCREENING SCALE. All aspects of the treatment will be explained to the participating patient with written Informed consent. Inclusion criteria satisfied will be included, exclusion criteria satisfied will be excluded. Patient selection by purposive sampling method and will be divided in two groups ‘A’ and ‘B’. 

30 patients enrolled in Group A will receive Shatavari kalpa 2 tsp (10 gms) once a day orally bhojanuttar with ushnodak (lukewarm water) for 4 weeks. 30 patients enrolled in Group B will receive Sattvavajay Chikitsain the form of Pranayam and meditation daily for 25 mins for 4 weeks with aashvasan chikitsa on every follow up and Shatavari kalpa 2tsp(10 gms) once a day orally bhojanuttar with ushnodak (lukewarm water) for 4 weeks.

Follow up will be taken with assessment of the patient on 0 day,1st week, 2nd week, 3rd week, 4th week. The data generated through clinical study will be subjected to unbiased statistical analysis to derive valid conclusions. 


 
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