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CTRI Number  CTRI/2025/10/096290 [Registered on: 22/10/2025] Trial Registered Prospectively
Last Modified On: 16/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Diagnostic 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Guduchi Sheetkashay and Dhanyak Sheetkashay in the management of Garbhini Chardi 
Scientific Title of Study   A comparative clinical study of Guduchi Sheetkashay and Dhanyak Sheetkashay in the management of Garbhini Chardi in first trimester 
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 Neha Subhash Rathod 
Designation  M.S. Scholar ( Prasutitantra avum Strirog ) 
Affiliation  Ashvin Rural Ayurved College, Manchi Hill, Ashvi Bk, Sangamner. Dist. Ahmadnagar 
Address  Right Wing, First Floor, Room No.1, PTSR Department,Ashvin Rural Ayurved College and Hospital, Sadvi Preetisudhaji Maharaj Nagar, Manchi Hill, Ashvi Bk, Tal. Sangamner. Dist. Ahmadnagar

Ahmadnagar
MAHARASHTRA
413714
India 
Phone  9403571195  
Fax    
Email  nsrathod25@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vidya Dattatraya Sarode 
Designation  Head of Department, Prasutitantra avum Strirog Department 
Affiliation  Ashvin Rural Ayurved College, Manchi Hill, Ashvi Bk, Sangamner. Dist. Ahmadnagar 
Address  Right Wing, First Floor, Room No.1, PTSR Department,Ashvin Rural Ayurved College and Hospital, Sadvi Preetisudhaji Maharaj Nagar, Manchi Hill, Ashvi Bk, Tal. Sangamner. Dist. Ahmadnagar

Ahmadnagar
MAHARASHTRA
413714
India 
Phone  8975019105  
Fax    
Email  vidya.sarode18@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Neha Subhash Rathod 
Designation  M.S. Scholar ( Prasutitantra avum Strirog ) 
Affiliation  Ashvin Rural Ayurved College, Manchi Hill, Ashvi Bk, Sangamner. Dist. Ahmadnagar 
Address  Right Wing, First Floor, Room No.1, PTSR Department,Ashvin Rural Ayurved College and Hospital, Sadvi Preetisudhaji Maharaj Nagar, Manchi Hill, Ashvi Bk, Tal. Sangamner. Dist. Ahmadnagar

Ahmadnagar
MAHARASHTRA
413714
India 
Phone  9403571195  
Fax    
Email  nsrathod25@gmail.com  
 
Source of Monetary or Material Support  
OPD of Prasutitantra avum Strirog Department, Ashvin Rural Ayurved College and Hospital, Sadvi Preetisudhaji Maharaj Nagar, Manchi Hill, Ashvi Bk. Tal Sangamner, Dist Ahmadnagar  
 
Primary Sponsor  
Name  Dr Neha Subhash Rathod 
Address  Right Wing, First Floor, Room No.1, PTSR Department, Ashvin Rural Ayurved College and Hospital, Sadvi preetisudhaji Maharaj Nagar, Manchi Hill, Ashvi Bk, Tal. Sangamner.Dist. Ahmadnagar, Maharashtra 
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 Neha Subhash Rathod  Ashvin Rural Ayurved College and Hospital, Manchi Hill, Ashvi Bk, Sangamner  Prasutitantra avum Strirog Department OPD, Ashvin Rural Ayurved College and Hospital, Sadvi Preetisudhaji Maharaj Nagar, Manchi Hill, Ashvi Bk, Tal. Sangamner Dist. Ahmadnagar
Ahmadnagar
MAHARASHTRA 		 9403571195

nsrathod25@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Ashvin Rural Ayurved College and Hospital, Manchi Hill, Ashvi Bk. Tal. Sangamner. Dist - Ahmadnagar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:O219||Vomiting of pregnancy, unspecified. Ayurveda Condition: GARBINYA VAMANAVYAPADAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Guduchi Sheetkashay, Reference: Sushrut Samhita, Uttartantra, Adhyay No.49, Shlok No.27, Route: Oral, Dosage Form: Sheeta/ Hima, Dose: 40(ml), Frequency: sos, Bhaishajya Kal: Muhurmuhu, Duration: 15 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Dhanyak Sheetkashay, Reference: Charak Samhita, Chikitsasthan, Adhyay No.20, Shlok No.31, Route: Oral, Dosage Form: Sheeta/ Hima, Dose: 40(ml), Frequency: sos, Bhaishajya Kal: Muhurmuhu, Duration: 15 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  1. All pregnant woman with Chardi in first trimester of pregnancy
2. Patients with pregnancy between 18-35 years of age
3. Patients willing for drug administration
4. Pregnant ladies with 3-4 episodes of vomiting 
 
ExclusionCriteria 
Details  1. Patients with hyperemesis gravidarum ( more than 4 episodes of vomiting )
2. Patients in whom Chardi is seen in second and third trimester of pregnancy
3. Pregnant women with vomiting due to other systemic diseases such as intestinal obstruction, appendicitis, etc
4. Pregnant women with known case of diabetes mellitus
5. patients with multiple pregnancy
6. Patients with complications like severe dehydration
7. A known case of HIV, tuberculosis 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the efficacy of Guduchi Sheetkashay and Dhanyak Sheetkashay in the management of Garbhini Chardi in first trimester  Total duration of medication will be 15 days 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NOT APPLICABLE 
 
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 
Date of First Enrollment (India)   28/11/2025 
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  

This study is a randomized, open label comparing the efficacy of Guduchi Sheetkashat and Dhanyak Sheetkashay for 18 months in 60 patients with Garbhini Chardi. 

Chardi is one of the Vyakta Garbha Lakshana.  This can be correlated with vomiting in pregnancy i.e. emesis gravidarum. Emesis gravidarum includes nausea associated with vomiting during the morning hours and sometimes continues throughout the day. Vomiting in pregnancy is a normal physiological change. Still it is important to monitor this problem during pregnancy. It may get converted to pathology if left untreated. So it should be treated as early as possible. The prevalence of this disease is 70%.

If it is not corrected on time it can cause increased intra-abdominal pressure which in turn causes threatened abortion, subchorionic bleeding. It can also cause maternal and fetal weight loss, antepartum haemorrhage, pre-eclampsia, low birth weight, prenatal death, fetal nutritional deficiency, Wernicke’s encephalopathy.

Garbha is totally dependent on mother for nutrition. Garbhini Chardi will affect the foetal growth.

Nutrition is best provided by enteral route. Orally liquid intake is necessary to prevent dehydration. Therefore giving Guduchi Sheetkashay  will be an appropriate management.
 
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