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CTRI Number  CTRI/2024/05/066625 [Registered on: 01/05/2024] Trial Registered Prospectively
Last Modified On: 22/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Diagnostic 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect Of Aartavpravartak Yog And Hingwaadi Tail (Uttarbasti and Yoni Varti) In The Management Of Oligomenorrhoea/Hypomenorrhoea 
Scientific Title of Study   A Clinical Study To Evaluate The Efficacy Of Aartavpravartak Yog And Hingwaadi Tail(Uttarbasti and Yoni Varti) In The Management Of Aartavkshaya. 
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 Seema Shukla 
Designation  Head of Department, Prasuti Tantra evum Stree Roga 
Affiliation  Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital  
Address  Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital, Paprola Distt. Kangra Himachal Pradesh INDIA

Kangra
HIMACHAL PRADESH
176115
India 
Phone  9418008833  
Fax    
Email  drseemanil@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Seema Shukla 
Designation  Head of Department, Prasuti Tantra evum Stree Roga 
Affiliation  Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital  
Address  Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital, Paprola Distt. Kangra Himachal Pradesh INDIA

Kangra
HIMACHAL PRADESH
176115
India 
Phone  9418008833  
Fax    
Email  drseemanil@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Abha Sharma 
Designation  PG Scholar, Department of Prasuti Tantra evum Stree Roga 
Affiliation  Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital  
Address  Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital, Paprola Distt. Kangra Himachal Pradesh INDIA

Kangra
HIMACHAL PRADESH
176115
India 
Phone  9805420020  
Fax    
Email  abha.rgh@gmail.com  
 
Source of Monetary or Material Support  
Charak Pharmacy, Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola, District Kangra, H.P. Research institute in ISM Jogindernagar, District Mandi, H.P.  
 
Primary Sponsor  
Name  Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital 
Address  Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital, Paprola District Kangra, Himachal Pradesh - 176115 Distt. Kangra Himachal Pradesh 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
HOD Department of Prasuti Tantra evum Stree Roga  Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital, Paprola Distt. Kangra 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Seema Shukla  Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital  OPD and IPD of Department of Prasuti Tantra evum Stree Roga, Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital, Paprola Distt. Kangra Himachal Pradesh
Kangra
HIMACHAL PRADESH 		 09418008833

drseemanil@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee(human) Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital, Paprola  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 ArmProcedure-uttara-bastiH, उत्तर-बस्तिः (Procedure Reference: Sushruta Chikitsasthaan 37/25, Procedure details: Aasthapan basti for two days followed by three days of uttarbasti then two days of rest followed by three days of uttarbasti for three consecutive menstrual cycle. Oral administration of Aartavpravrtak Yog - 2gm BD for three consecutive months.)
(1) Medicine Name: Hingwaadi Taila, Reference: Bhaishjya Ratnavali 67/118-119, Route: Vaginal, Dosage Form: Taila, Dose: 2(ml), Frequency: od, Duration: 3 Months
2Comparator ArmProcedure-yoni varti, योनि वर्ति (Procedure Reference: Bhaishjya Ratnavali 67/118-119, Procedure details: Six days of Yoni Varti with hingwaadi taila for three consecutive menstrual cycle. Oral administration of Aartavpravartak Yog 2gm BD for three consecutive months.)
(1) Medicine Name: Hingwaadi Taila, Reference: Bhaishjya Ratnavali 67/118-119, Route: Vaginal, Dosage Form: Varti/ Suppository, Dose: 2(ml), Frequency: od, Duration: 3 Months
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1.Patients willing to give consent and able to participate in the trial.
2.Married female patients between age group of 18 to 40 years.
3.Clinically diagnosed patients which fell under symptomatic criteria of
Aartavakshaya 
 
ExclusionCriteria 
Details  1.Patients not willing and not giving consent to participate in the trial.
2.Age of patient more than 40 years of age or less than 18 years of age.
3.Patient having diseases like hypertension, tuberculosis, nephritis, diabetes and
heart diseases.
4.Patient having veneral diseases.
5.Pregnant women, lactating women and women using OCP’s.
6.Unmarried females.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement which will be shown by patients in sign and symptoms  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Overall improvement which will be shown by patients in sign & symptoms  4 months 
 
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/ Phase 4 
Date of First Enrollment (India)   21/05/2024 
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="3"
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  
Research Report will be soon published after the completion of trial. 
30 patients fulfilling the inclusion and exclusion criteria will be randomly selected from the OPD and IPD of
Department of Prasuti Tantra evum Stree Roga, RGGPG Ayurvedic College and Hospital, Paprola.
Patients will be divided randomly into 2 group: Group I and Group II each with 15 patients. 
Group I will be given Uttarbasti with Hingwaadi Taila along with oral administration of Artavapravartak Yog.
Group II will be given Hingwaadi Taila Yoni Varti along with oral administration of Aartavpravartak Yog.
FOLLOW UP STUDY:   
DURING TRIAL :-
1st follow up – after clearance of mensuration of 1st cycle 
2nd follow up – after clearance of mensuration of 2nd cycle 
AFTER TRIAL :-
3rd follow up – after clearance of mensuration of 3rd cycle.
CRITERIA OF ASSESSMENT:  
All the subjects registered for the trial will be assessed on the basis of subjective parameters and objective parameters.
 
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