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CTRI Number  CTRI/2023/10/058253 [Registered on: 04/10/2023] Trial Registered Prospectively
Last Modified On: 27/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Effect Of Soubhagya Shunthi Leha In Sutika Makkala(Puerperal Pain) 
Scientific Title of Study   A Clinical Study To Evaluate The Effect Of Soubhagya Shunthi Leha In The Management Of Sutika Makkala (Puerperal pain) 
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 Reeta C Vajramatti  
Designation  P G Scholar 
Affiliation  Sidramappa Danigond Memorial Trusts Ayurvedic Medical College Post Graduation Centre Terdal  
Address  SDM Trusts Ayurvedic Medical college Danigond Post Graduation Centre Padma Ayurvedic Hospital And Research Centre Dr Siddhant Nagar Terdal 587315

Bagalkot
KARNATAKA
587315
India 
Phone  9449532200  
Fax    
Email  vajramattireeta@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Parashuram K Rawal  
Designation  Professor And HOD  
Affiliation  Sidramappa Danigond Memorial Trusts Ayurvedic Medical College Post Graduation Centre 
Address  SDM Trusts Ayurvedic Medical college Danigond Post Graduation Centre Padma Ayurvedic Hospital And Research Centre Dr Siddhant Nagar Terdal 587315

Bagalkot
KARNATAKA
587315
India 
Phone  9880976151  
Fax    
Email  Chaitanya.rawal5@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Reeta C Vajramatti  
Designation  P G Scholar 
Affiliation  Sidramappa Danigond Memorial Trusts Ayurvedic Medical College Post Graduation Centre Terdal  
Address  SDM Trusts Ayurvedic Medical college Danigond Post Graduation Centre Padma Ayurvedic Hospital And Research Centre Dr Siddhant Nagar Terdal 587315

Bagalkot
KARNATAKA
587315
India 
Phone  9449532200  
Fax    
Email  vajramattireeta@gmail.com  
 
Source of Monetary or Material Support  
SDM Trusts Ayurvedic Medical College Post Graduation Centre Terdal 
 
Primary Sponsor  
Name  Dr Reeta C Vajramatti  
Address  SDM Trusts Ayurvedic Medical college Danigond Post Graduation Centre Padma Ayurvedic Hospital And Research Centre Dr Siddhant Nagar Terdal 587315 
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 Reeta C Vajramatti  Padma Ayurvedic Hospital And Research Centre  OPD And IPD Department of Prasuti Tantra And Stree Roga Ground Floor Padma Ayurvedic Hospital And Research Centre 587315 Bagalkot KARNATAKA
Bagalkot
KARNATAKA 		 9449532200

vajramattireeta@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SDMTs Ayurvedic Medical College and Padma Ayurvedic Hospital INSTITUTIONAL ETHICS COMMITTEE FOR RESEARCH ON HUMAN SUBJECTS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:O909||Complication of the puerperium, unspecified. Ayurveda Condition: SUTIKAROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Soubhagya Shunthi Leha, Reference: Bhaishajya Ratnavali Sutika Rogadhikara, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: Sukhoshna Jala), Additional Information: -
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  1.Married patients both primi Para and multi Para are taken.
2.Patients with full term normal vaginal delivery.
3.Patients willing to sign the consent form. 
 
ExclusionCriteria 
Details  1.Patients with Complication of IUD, Sepsis, PIH, and third stage of labour.
2.Patients with Systematic Disorders like Diabetes Mellitus, Hypertension, and Tuberculosis.
3.Instrumental Delivery, LSCS patients.
4.K|C|O –STDs, HIV, HBsAG.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Effect of trial drug on the symptoms Udara Shoola, Adhmana, Shirashoola, Bastishools of Sutika Makkala(Puerperal pain).  15th day , 30th day 
 
Secondary Outcome  
Outcome  TimePoints 
Safety of trial drug and Adverse Drug Reaction
Aggravation of Symptoms of Sutika Makkala(Puerperal pain) 		 15th day, 30th day 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 3 
Date of First Enrollment (India)   10/10/2023 
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  

  • Sutika Makkala is one among 74 Sutika vyadi’s. Sutika Makkala occurs due to aggravation of vata Dosha and incomplete evacuation of Shonita from the Garbhashaya after Prasava that cause Shoola in Basti, Shiras and Udara.
  • Sutika Makkala can be co- related to "Puerperal pain" characterized infrequent spasmodic pain in lower abdomen due to hypertonic contraction of the uterus to expel remainants of blood clots or any bits.
  • Soubhagya shunti leha mentioned Bhaishajya Ratnavali is selected for this study to evaluate its effect in the management of Sutika Makkala(Puerperal pain).
  • This is a single arm open label clinical trial. Total 30 patient of Sutika Makkala who fulfill the inclusion criteria & diagnostic criteria based on clinical sign and symptoms of Sutika Makkala are selected.
  • Total Study duration will be 30 days and contain 3 visits (0th day, 15th day, 30th day), which includes administration of trial drug for 15 days and post medication follow up 30th days.
  • After study, data will be collected from case report form (CRF) and statistically analyzed by using appropriate parametric and non-parametric tests and results will be obtained. On that basis results and conclusion will be drawn.

 
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