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CTRI Number  CTRI/2025/01/079184 [Registered on: 21/01/2025] Trial Registered Prospectively
Last Modified On: 21/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Basti Therapy ]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A comparative study between Oral Rasnadarvadi Kashaya combined with Trivrit Taila Anuvasana Basti and Oral Saptasara Kashaya combined with Shatpushpa Tail Anuavasana Basti in management of Kashtartava with reference to Primary Dysmenorrhoea 
Scientific Title of Study   A Comparative Study on the Effect of Rasnadarvadi Kashaya Orally along with Trivrit Taila Anuvasana Basti and Saptasara Kashaya Orally along with Shatpushpa Taila Anuvasana Basti in Kashtartava with special reference to Primary Dysmenorrhoea 
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 Sujata Admane  
Designation  Junior Resident  
Affiliation  Banaras Hindu University 
Address  Department of Prasuti Tantra Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  8421121206  
Fax    
Email  sujataadmane873@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Vishwesh B N 
Designation  Professor and Head of Department  
Affiliation  Banaras Hindu University  
Address  Department of Prasuti Tantra Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  8277033135  
Fax    
Email  vishweshbn@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prof Vishwesh B N 
Designation  Professor and Head of Department  
Affiliation  Banaras Hindu University  
Address  Department of Prasuti Tantra Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  8277033135  
Fax    
Email  vishweshbn@gmail.com  
 
Source of Monetary or Material Support  
Sir Sundarlal Hospital Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi  
 
Primary Sponsor  
Name  Faculty of Ayurveda Institute of Medical Sciences BHU 
Address  OPD no 24 Prasuti Tantra OPD Department of Prasuti Tantra Faculty of Ayurveda IMS BHU Varanasi 
Type of Sponsor  Research institution and 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 Sujata Admane   Sir Sunderlal Hospital BHU  OPD no 24 Prasuti Tantra OPD Department of Prasuti tantra Faculty of Ayurveda BHU
Varanasi
UTTAR PRADESH 		 8421121206

sujataadmane873@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N944||Primary dysmenorrhea. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-bastikarma, बस्तिकर्म (Procedure Reference: Sushrut sutra 37/4, Procedure details: Installation of 60ml Shatpusha Taila rectally after taking food for 8days )
(1) Medicine Name: Shatpusha Taila , Reference: Kashyap kalpasthana 5/5-6, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 8 Days
2Comparator ArmDrugClassical(1) Medicine Name: Rasnadarvyadi kashaya , Reference: Sahatrayoga kashaya yog prakarana 443/1-2, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: -
(2) Medicine Name: Saptasara Kashaya , Reference: Sahatrayoga kashaya yog prakarana 43/1-2, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: -
3Comparator ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: Sushrut sutra 37/4, Procedure details: Installation of 60ml trivrit oil rectally After taking food for 8days)
(1) Medicine Name: Trivrit Taila , Reference: Charak chikitsa 30/110-111, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 8 Days
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  30.00 Year(s)
Gender  Female 
Details 
1. Age group 16 -30 years.
2. Patients complaining of painful menstruation for at least 2 consecutive cycles.
3. Patients having regular menstrual cycle.
4. Patients who are ready for necessary investigations and agreed to come for follow up
regularly.
5. Patients who are ready for the trial and ready to sign the informed consent.
 
 
ExclusionCriteria 
Details  1.Patient of age less than 16 and above the age of 30 years.
2.Patients with any history of allergy
3.Pregnant women
4.Women with chronic ailments (systemic diseases like TB, DM, jaundice, bronchial asthma, cardiovascular diseases)
5.Patients having anorectal diseases.
6.Patient having any history of psychological disorders.
7.Patients having their HIV, VDRL and Hepatitis reactive.
8.Patient having congenital anomalies leading to dysmenorrhoea.
9.Patient having pelvic inflammatory disease and any pelvic pathology .
10.Patient taking any hormonal therapy and IUCD 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Based on assessment criteria 1.Pain in lower abdomen, low back or medial aspect of thighs during menses (VAS scale and WaLIDD score).
2.Duration of pain
3.Characteristic of menstrual blood
Amount of bleeding
4.Clinical features like Praseka/Chhardi (Nausea/Vomiting)
Bhrama (Vertigo)
Atisara (Diarrhoea)
Shirhshoola (Headache)
Vibhandha (Constipation) 		 4 follow up with equal interval of 30 days 
 
Secondary Outcome  
Outcome  TimePoints 
Reduced Pain and associated symptoms   4 follow ups with Regular interval of 30 days.3 follow ups with medication and 1 follow up without medication 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   01/02/2025 
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="5" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   Primary dysmenorrhea is common complaint among reproductive age females. It is characterized by painful menses. Pain is spasmodic and confined to lower abdomen, may radiate to back and medial aspect of thighs associated with other physical and/or psychological symptoms. According to ayurveda all gynaecological disorders are caused by vitiation of vata dosha and they are described under Yoni vyapada. In present study an attempt made to correlate Primary Dysmenorrhea with Kashtartava (Udavartini /Vataja Yoni Vyapad) as mentioned in ayurvedic classics and to compare the effect of Rasnadarvadi Kashaya orally along with Trivrit Taila Anuvasana Basti and Saptasara Kashaya orally along with Shatpushpa Taila Anuvasana Basti in Primary dysmenorrhea. 
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