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CTRI Number  CTRI/2025/02/080569 [Registered on: 14/02/2025] Trial Registered Prospectively
Last Modified On: 10/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Efficacy of balaguduchyadi taila enema in comparison to sahacharadi taila enema in udavartini yoni vyapat - dysmenorrhea 
Scientific Title of Study   Efficacy of balaguduchyadi taila matra basti in comparison to sahacharadi taila matra basti in udavartini yoni vyapat - dysmenorrhea - a randomized clinical trial 
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 M B Chinamayee 
Designation  Post Graduation Scholar, Department of Prasooti tantra evam Stri roga 
Affiliation  SDM Institute of Ayurveda College and Hospital, Anchepalya, Kumbalagodu post, Bangalore  
Address  SDM Institute of Ayurveda College and Hospital, Anchepalya, Kumbalagodu post, Bangalore-Mysore Highway, Bangalore-560074, Karnataka, India

Bangalore
KARNATAKA
560074
India 
Phone  8660061186  
Fax    
Email  chinamayee3@gmail,com  
 
Details of Contact Person
Scientific Query  
Name  Dr Padmasaritha K 
Designation  Professor and Head, Department of Prasooti tantra evam  
Affiliation  SDM Institute of Ayurveda College and Hospital, Anchepalya, Kumbalagodu post, Bangalore  
Address  SDM Institute of Ayurveda College and Hospital, Anchepalya, Kumbalagodu post, Bangalore-Mysore Highway, Bangalore-560074, Karnataka, India

Bangalore
KARNATAKA
560074
India 
Phone  7353254151  
Fax    
Email  Padmasarithareddy@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr M B Chinamayee 
Designation  Post Graduation Scholar, Department of Prasooti tantra evam Stri roga 
Affiliation  SDM Institute of Ayurveda College and Hospital, Anchepalya, Kumbalagodu post, Bangalore  
Address  SDM Institute of Ayurveda College and Hospital, Anchepalya, Kumbalagodu post, Bangalore-Mysore Highway, Bangalore-560074, Karnataka, India

Bangalore
KARNATAKA
560074
India 
Phone  8660061186  
Fax    
Email  chinamayee3@gmail,com  
 
Source of Monetary or Material Support  
Department of Prasooti tantra evam Stri roga- 24,4,5,6,20,29 Shri Dharmasthala Manjunatheshwara Institute of Ayurveda College and Hospital, Anchepalya, Bangalore- 560074 
 
Primary Sponsor  
Name  Shri Dharmasthala Manjunatheshwara Institute of Ayurveda College and Hospital, Bangalore  
Address  Shri Dharmasthala Manjunatheshwara Institute of Ayurveda College and Hospital,Anchepalya Bangalore, Karnataka  
Type of Sponsor  Private medical college 
 
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 M B Chinamayee  Shri Dharmasthala Manjunatheshwara Institute of Ayurveda College and Hospital, Bangalore  Department of Prasooti tantra evam Stri roga, OPD number-24,6,5,4,20,29.
Bangalore
KARNATAKA 		 8660061186

chinamayee3@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Sri Dharmasthala Manjunatheshwara Institute of Ayurveda And Hospital, Anchepalya, Kumbalgodu Post Mysore Road, Bengaluru-560074, Karnataka, India Phone: 9741562586, email ID: sdmcabh@gmail.com  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N946||Dysmenorrhea, unspecified. Ayurveda Condition: UDAVARTINI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-mAtrAbastiH, मात्राबस्तिः (Procedure Reference: Charaka samhita, Siddhisthana, 4th Chapter- Snehavyapatsiddhi adhyaya, 52-54th shloka, Procedure details: • Ask patient to lie down in left lateral position with strait of left leg and fully flexion of right leg from knee and hip joint • Apply oil for lubrication on local anal region and as well as on the catheter/ nasal of instrument • Remove air from basti instrument and slowly insert the nozzle in the anal canal upto 4 angula • Then administer basti dravya by steady pressure • Ask patient to take deep breath with mouth during the procedure • Place cotton piece at anal region • Ask patient to lie down in supine position)
(1) Medicine Name: Sahacharadi taila, Reference: Ashtanga hridaya, Chikitsasthana, 21st chapter, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 7 Days
2Intervention ArmProcedure-mAtrAbastiH, मात्राबस्तिः (Procedure Reference: Charaka samhita, Siddhisthana, 4th Chapter- Snehavyapatsiddhi adhyaya, 52-54th shloka, Procedure details: • Ask patient to lie down in left lateral position with strait of left leg and fully flexion of right leg from knee and hip joint • Apply oil for lubrication on local anal region and as well as on the catheter/ nasal of instrument • Remove air from basti instrument and slowly insert the nozzle in the anal canal upto 4 angula • Then administer basti dravya by steady pressure • Ask patient to take deep breath with mouth during the procedure • Place cotton piece at anal region • Ask patient to lie down in supine position)
(1) Medicine Name: Balaguduchyadi taila, Reference: sahasrayoga, taila prakarana, 14, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Both married and unmarried women with painful menstruation without pelvic pathology, Patients with age between 18 to 35 years, Patients fulfilling the diagnostic criteria
 
 
ExclusionCriteria 
Details  Congenital anomalies of genital tract, Dysmenorrhea with pelvic pathology- Fibroid uterus, ovarian cyst, Malignancy, IUCD; Patients with any Systemic Diseases- DM, HTN, TB; Rectal pathologies like haemorrhoids, fissure, fistula; Patients with diarrhea 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in Pain as assessed by DVPRS scale
Decrease in severity of Udavartini yonivyapat- dysmenorrhea based on VMSS scale. 		 At baseline, 7th day, 37th day and 67th day  
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in quality of life by reducing the signs and symptoms of Udavartini yonivyapat- dysmenorrhea.  3 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 2/ Phase 3 
Date of First Enrollment (India)   09/03/2025 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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   Efficacy of Balaguduchyadi taila matra basti in comparison to Sahacharadi taila matrabasti in comparison to Udavartini yonivyapat- Dysmenorrhea - A Randomised clinical study. In my study i have taken 2 groups. Group1 is of trial drug Balaguduchyadi taila matra basti and Group 2 is of control drug Sahacharadi taila matrabasti. Medicine will be selected by computer cheat methods. Here both the participant and investigator will know the drug which is selected. Duration of procedure is 7 days after 48 hours of cessation of menstruation and follow-up will be done for 2 consecutive menstrual cycles, total duration of study is 3 menstrual cycles. Methodology is Interventional(clinical) for study group- 18-35 years old female patients with featiures of Udavartini yoni vyapat-Dysmenorrhea attending Prasooti tantra evan Stri roga out-patient department in Shri Dharmasthala Manjunatheshwara Institute of Ayurveda College and Hospital, Bangalore.Methodology is Interventional(clinical) for control group- 18-35 years old female patients with featiures of Udavartini yoni vyapat-Dysmenorrhea attending Prasooti tantra evan Stri roga out-patient department in Shri Dharmasthala Manjunatheshwara Institute of Ayurveda College and Hospital, Bangalore. 
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