| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O909||Complication of the puerperium, unspecified. Ayurveda Condition: MAKKALLAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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 |