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CTRI Number  CTRI/2025/12/099346 [Registered on: 17/12/2025] Trial Registered Prospectively
Last Modified On: 25/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   use of Shitkalyanaka Ghrita in Artavakshaya (oligomenorrhea) 
Scientific Title of Study   CLINICAL STUDY TO EVALUATE THE EFFICACY OF SHITKALYANAKA GHRITA IN THE MANAGEMENT OF ARTAVAKSHAYA W.S.R TO OLIGOMENORRHEA. 
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 Heena 
Designation  MS PG Scholar 
Affiliation  Jeevan Jyoti Ayurvedic Medical College & Hospital 
Address  Room no 203 second floor Jeevan Jyoti Ayurvedic Medical College and Hospital
Aligarh Palwal Rd Lodha Uttar Pradesh 202140
Aligarh
UTTAR PRADESH
202140
India 
Phone  9310442660  
Fax    
Email  Kashyapheena15@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mamata kumari swain  
Designation  MD ayurveda HOD Department of PG Studies in Prasutitantra evam Stree Roga 
Affiliation  Jeevan Jyoti Ayurvedic Medical College & Hospital 
Address  Room no 203 second floor Jeevan Jyoti Ayurvedic Medical College and Hospital
Aligarh Palwal Rd Lodha Uttar Pradesh 202140
Aligarh
UTTAR PRADESH
202140
India 
Phone  9348576189  
Fax    
Email  swaindrmamata@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Mamata kumari swain  
Designation  MD ayurveda HOD Department of PG Studies in Prasutitantra evam Stree Roga 
Affiliation  Jeevan Jyoti Ayurvedic Medical College & Hospital 
Address  Room no 203 second floor Jeevan Jyoti Ayurvedic Medical College and Hospital
Aligarh Palwal Rd Lodha Uttar Pradesh 202140
Aligarh
UTTAR PRADESH
202140
India 
Phone  9348576189  
Fax    
Email  swaindrmamata@gmail.com  
 
Source of Monetary or Material Support  
Jeevan Jyoti Ayurvedic Medical College & Hospital Aligarh - Palwal Rd, Lodha, Uttar Pradesh 202140 
 
Primary Sponsor  
Name  Dr. Heena 
Address  Jeevan Jyoti Ayurvedic Medical College & Hospital Aligarh - Palwal Rd, Lodha, Uttar Pradesh 202140 
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 Heena  Room no 203 second floor Jeevan Jyoti Ayurvedic Medical College and Hospital Aligarh   Aligarh - Palwal Rd, Lodha, Uttar Pradesh 202140
Aligarh
UTTAR PRADESH 		 9310442660

Kashyapheena15@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr rabi narayan mahanta  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N915||Oligomenorrhea, unspecified. Ayurveda Condition: ARTAVAKSHAYAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: SHITKALYANAKA GHRITA, Reference: Bhaisajya Ratanavali, Route: Oral, Dosage Form: Ghrita, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -luke warm milk), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1. Age group 18 to 40 years.
2. Interval between two menstrual cycles is greater than 35 days (for the
last three months approximately).
3. Duration of menstrual flow is two days or less (for the last three
months approximately).
4. Patients complaining of alpartava and yonishool.
5. Pain during menses. 
 
ExclusionCriteria 
Details  1. Patients below age of 18 years and above age of 40 years.
2. Positive history of venereal diseases (HIV, HBsAg, anti HCV, VDRL, HPV etc.)
3. Patient having congenital anomalies and structural defect in female genital
4. Patient having chronic systemic disease like DM , cardiac vascular disease 
 
Method of Generating Random Sequence   Other 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement in amount of menstrual blood  3 month
the trail drug will be given for 3 months with anupana and follow up will be done after every menstrual cycle 
 
Secondary Outcome  
Outcome  TimePoints 
improvement in duration of menstrual bleeding and interval between two cycles  after analyzing all the parameters the result will be assessed on the basis of symptomatic relief and improvement.
partial improvement after 15 days- patient get 30 percent relief from sign and symptoms
improvement after 1 month- patient get 40-50 percent relief from sign and symptom
improvement after 2 month- patient get 60-80 percent relief from sign and symptom
cured after 3 month- patient get 81-100 percent relief from sign and symptom 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   26/12/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  26/12/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="10"
Days="10" 
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  
The condition characterized with very scanty menstrual bleeding.
Artavakshaya is not a disease but a symptom of various underlaying health conditions. however depending on the etiopathogenesis Artavakshaya occurs due to Dosha has obstruct the passage or orifice of channels 
carrying Artava thus Artava is destroyed. their are several drug of Artavakshaya but here I have chosen SHITKALYANAKA GHRITA which not only treats symptoms but also does samprapti bhanga.
Therefore I have selected 40  patients aged between 18-40 years, patients should be selected on the basis of inclusion and exclusion criteria. The trial will be of 3 consecutive months and follow up will be done after each months. Cured after 3 months patient gets 80-100percent rellef from sign and symptoms.
 
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