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CTRI Number  CTRI/2025/05/086634 [Registered on: 09/05/2025] Trial Registered Prospectively
Last Modified On: 08/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   To Study The Effect Of Yavakshara In Pain after Delivery in Post Partum Mother 
Scientific Title of Study   A Single Arm Open Labelled Clinical Study To Evaluate The Efficacy Of Yavakshara In Sutika Makkala With Special Reference To Puerperal After Pains 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Geetam Sidharth Waghmare  
Designation  Post graduate resident 
Affiliation  APMs Ayurved Mahavidyalaya,Sion  
Address  At post. Dharmabad, Sarthak Niwas, Rasik nagar, Nagsen Parisar, Tq Dharmabad, Dist. Nanded
Department of Prasuti Tantra and Stri Roga, APMs Ayurved Mahavidyalaya, Near Sion Railway Station, Sion East, Mumbai 400022 Mumbai MAHARASHTRA
Mumbai
MAHARASHTRA
431809
India 
Phone  9767961583  
Fax    
Email  geet2697@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Geetam Sidharth Waghmare  
Designation  Post graduate resident 
Affiliation  APMs Ayurved Mahavidyalaya,Sion  
Address  At post. Dharmabad, Sarthak Niwas, Rasik nagar, Nagsen Parisar, Tq Dharmabad, Dist. Nanded
Department of Prasuti Tantra and Stri Roga, APMs Ayurved Mahavidyalaya, Near Sion Railway Station, Sion East, Mumbai 400022 Mumbai MAHARASHTRA
Mumbai
MAHARASHTRA
431809
India 
Phone  9767961583  
Fax    
Email  geet2697@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Priya Jayant Walwatkar 
Designation  Asso Professor  
Affiliation  APMs Ayurved Mahavidyalaya,Sion  
Address  Department of Prasuti Tantra and Stri Roga, APMs Ayurved Mahavidyalaya, Near Sion Railway Station, Sion East, Mumbai 400022

Mumbai
MAHARASHTRA
400022
India 
Phone  9820682568  
Fax    
Email  priyawalwatkar@gmail.com  
 
Source of Monetary or Material Support  
Seth R V Ayurved Hospital 
 
Primary Sponsor  
Name  Seth RV Ayurved Hospital  
Address  Near Sion Railway Station, Sion East, Mumbai 400022 
Type of Sponsor  Other [Charitable Ayurvedic Hospital ] 
 
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 Geetam Sidharth Waghmare  Seth R V Ayurved Hospital   OPD NO 8 Department of Streerog And Prasutitantra Seth R V Ayurved hospital Near Sion Railway Station, Sion East, Mumbai 22 Mumbai MAHARASHTRA
Mumbai
MAHARASHTRA 
9767961583

geet2697@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
APMs Ayurvedic Mahavidyalaya Sion IEC  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: MAKKALLAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Yavakshara, Reference: Yogaratnakar Samhita Uttarardha Adhyaya Sutika Rogadhikar Makkal Chikitsa Shlok no 1, Route: Oral, Dosage Form: Kshara , Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Ushnodaka ), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Patients of normal vaginal delivery Irrespective of parity and gravida
Women having abdominal pain from 2nd day upto to 7
th day of delivery
Patient of all socio Economical status
Patient willing for participate in research with informed consent
 
 
ExclusionCriteria 
Details  Patients with severe anaemia
Patient with Gestational Diebetes Mallitus
Immuno-Compromised Patients
Patient with LSCS
Patient with Previous abdominal surgeries
Sutika having any ovarion or uterine pathology diagnosed on USG 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Pain in abdomen  7 days 
 
Secondary Outcome  
Outcome  TimePoints 
Agni, Involusion of uterus,Lochia amount, Retension of urine   7 days 
 
Target Sample Size   Total Sample Size="35"
Sample Size from India="35" 
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 4 
Date of First Enrollment (India)   25/05/2025 
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  
 In Ayurveda the period after childbirth is referred to as Sutika Awastha a delicate phase during which the womans body gradually returns to its prepregnancy state This period begins only after the complete expulsion of the fetus and placenta as per Ayurvedic texts like Kashyap Samhita
Due to the exertion of labor and the loss of vital elements such as Kleda bodily fluids Rakta blood and Dhatus body tissues the mothers body becomes weak and more vulnerable to diseases Aacharya Charaka describes the postpartum body as a Shunyasharir empty body highly susceptible to Vataprakopa aggravation of Vata dosha
Sutika Makkala is one of the 64 disorders of the postpartum phase mentioned by Aacharya Kashyap It is caused by retained blood in the uterus due to aggravated Vata body dryness and absence of purificatory measures This leads to Severe lower abdominal pain Bladder discomfort
Bloating Retention of urine Pricking sensations
In modern medical terms Sutika Makkala corresponds to Puerperal After Pains which are infrequent spasmodic pains in the lower abdomen that may last for 2 4 days postdelivery due to the presence of blood clots and uterine contractions as the uterus returns to its normal size According to classical Ayurvedic texts vitiated Vata is considered the primary cause of most postpartum disorder including Sutika Makkala This condition marked by abdominal pain bloating and urinary retention arises due to Dhatukshaya tissue depletion and Vataprakopa aggravated Vata following childbirth Effective treatment therefore requires the use of medicines with Vatashamak Vata-pacifying Shoolhara painrelieving and Garbhashaya Shodhak uterine cleansing properties These therapeutic actions help in
Replenishing depleted Dhatus Reducing Vata aggravation Alleviating abdominal pain and bloating Improving strength and vitality
One such formulation described in classical texts like Yogaratnakara is Yavakshara which is indicated for internal use in managing Sutika Makkala Key Features of Yavakshara Prepared from Yava barley ash
Chemically Carbonate of potash Contains Silicic acid phosphoric acid iron and lime Properties Stomachic laxative diuretic antacid resolvent Rasa Katu Vipaka Katu Virya Ushna hot Guna Laghu light Snigdha unctuou Sar mobility These properties make Yavakshara highly effective 
The Anupan  used is Ushnodaka  which enhances digestion Deepan cleanses the bladder Bastishodhak and supports VataKapha balance
Based on its Ayurvedic pharmacological profile Yavakshara is a promising herbalmineral formulation for managing Sutika Makkala and its clinical effectiveness is worth evaluating through systematic observation
In many societies this pain is often overlooked as a normal part of recovery However neglecting puerperal pain can delay healing and impact the mothers ability to care for her newborn potentially affecting both maternal and infant wellbeing Postpartum care is crucial, as the mothers health has a direct impact on the childs development In modern medicine this condition is managed using analgesics antiinflammatories and antispasmodics which can sometimes lead to side effects Conversely Ayurveda offers a range of herbal formulations like Kwathas Churnas and Arishtas which aim not just at symptom relief but holistic recovery with minimal adverse effects Yavakshara a classical Ayurvedic formulation has shown potential due to its Vata-Kapha pacifying Shoolhara and Garbhashaya Shodhak properties It is cost-effective easily available and clinically potent making it a suitable candidate for managing Sutika Makkala This study is proposed to evaluate the effectiveness and safety of Yavakshara in reducing symptoms of Sutika Makkala thereby contributing to better postpartum care through Ayurvedic principles
 
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