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CTRI Number  CTRI/2024/03/063422 [Registered on: 01/03/2024] Trial Registered Prospectively
Last Modified On: 29/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Guduchyadi Taila Uttar Basti and Rasnadi Ksheerpaka Orally in Vataja Yonivyapad  
Scientific Title of Study   A Comparative Clinical Study on the Therapeutic Effect of Guduchyadi Taila Uttar Basti and Rasnadi Ksheerpaka Orally in Vataja Yonivyapad  
Trial Acronym  No 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mamta Singh Yadav 
Designation  MS Scholar 
Affiliation  Institute of Medical Sciences BHU 
Address  Department of Prasuti Tantra Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi Uttar Pradesh
Room no 68 kasturba girls hostel IMS BHU
Varanasi
UTTAR PRADESH
221005
India 
Phone  9616941751  
Fax    
Email  mamtaanu09@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mamta Singh Yadav 
Designation  MS Scholar 
Affiliation  Institute of Medical Sciences BHU 
Address  Department of Prasuti Tantra Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi Uttar Pradesh
Room no 68 Kasturba Gandhi hostel IMS BHU
Varanasi
UTTAR PRADESH
221005
India 
Phone  9616941751  
Fax    
Email  mamtaanu09@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prof Deepa Mishra 
Designation  Professor 
Affiliation  Institute of Medical Sciences BHU 
Address  Department of Prasuti Tantra Faculty of Ayurveda Institute of Medical Science BHU Varanasi UP
Manduadeh near Varanasi UP
Varanasi
UTTAR PRADESH
221005
India 
Phone  9650453095  
Fax    
Email  deepa1971mishra@gmail.com  
 
Source of Monetary or Material Support  
Sir Sundarlal Hospital Faculty of Ayurveda IMS BHU 
 
Primary Sponsor  
Name  Department of Prasuti Tantra 
Address  Faculty of Ayurveda Institute of Medical Sciences Banarus Hindu University 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 Mamta Singh Yadav  Sir Sundarlal Hospital BHU  OPD No 24 prasuti tantra department of prasuti tantra faculty of ayurveda IMS BHU
Varanasi
UTTAR PRADESH 		 9616941751

mamtaanu09@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ECR/526/Inst/UP/2014/RR-20 dt 19/05/2020  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: YONIROGAH/YONI-VYAPADAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-uttara-bastiH, उत्तर-बस्तिः (Procedure Reference: c.si.9/67-68, Procedure details: uttar basti should be given to pt in lithotomy position. the catheter should be inserted comfortably in the direction of vertebral column .two three or four unctuous recipe should be administerd into the bladder during the course of a day and night. the procedure should be done three night by gradually inc the dose .)
(1) Medicine Name: guduchiyadi taila, Reference: c.chi.30/, Route: Vaginal, Dosage Form: Taila, Dose: 4(ml), Frequency: od, Duration: 4 Days
2Intervention ArmDrugClassical(1) Medicine Name: rasnadi ksheerpaka, Reference: A.H.U.34/33, Route: Oral, Dosage Form: Ksheerpaka, Dose: 48(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: intake of shritpaya prepared by rasna vasa gokshura cures pain in reproductive organ
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1.Married women of 20-40 years of age.
2. Patient having complaint of pain during menses along with one or more than one symptomatology from the following at least two previous consecutive cycle-
(a)Pain in abdomen during menses.
(b)Decrease duration of menstrual blood [duration of blood loss is 2 days or less than 2 day].
(c)Decrease amount of menstrual blood [quantity of menstrual is less than 20ml].
(d)With thin, dry, frothy characteristic of menstrual blood.
(e)Sensory symptoms numbness, roughness or stiffness in genital region.
(f)Associated symptoms nausea, vomiting, bodyache, headache. 
 
ExclusionCriteria 
Details  1.Women below 20 years and above 45 years of age.
2.Unmarried or Pregnant women
3.Women with systemic diseases like TB, DM, Jaundice, Bronchial Asthma, Cardiovascular diseases, Renal diseases or Acute gastrointestinal conditions like Appendicitis, Cholecystitis, Hepatitis, pancreatitis, gastric ulcer.
4.Women having complaint of Menorrhagia.
5.Patients having STD, Carcinoma of Cervix, Large cervical polyp, Acute active genital infections, bartholin abscess, Large bartholin cyst, large vaginal cyst, large, polypoidal fibroid, Uterine prolapse (2or 3degree), extensive ectropion.
6.Skin disease in perineal region like eczema, herpes.
7.Patient is on chemotherapy / radio therapy for any malignant condition of any organ.
8.Women having any psychological disorders.
9.Women having lactose intolerance. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Assessment will be done on the following parameters:
Dysmenorrhea (WaLIDD Score)
Pelvic pain (VAS Scale)
Amount of menstrual blood loss
Duration of blood loss
Colour of menstrual blood
Fatigue / lethargy
Characteristic of menstrual blood thin/dry/frothy in nature
Sensory changes numbness, stiffness, roughness in genital region.
Associated symptoms nausea, vomiting, bodyache headache. 		 Two month with medication and one month with out medication  
 
Secondary Outcome  
Outcome  TimePoints 
Reduce pelvic pain and improvement in sensory changes numbness stiffness roughness of genital region  two follow up with medication and one follow up without medication total 90 days duration  
 
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)   01/05/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/05/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="0"
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  
Yonivyapad in modern science correlated with gynaecological problem and Vataja Yonivyapad may be corelated with the dysmenorrhea because pelvic pain is the main characteristic of Vataja Yonivyapad with other changes in characteristic of menstruation.It is a most common gynaecological problem in female of reproductive age group, which affects physical as well as mental status of life in females. Dysmenorrhea is painful menstruation of sufficient magnitude to incapacitate day to day activity.
 Guduchiyadi taila uttar basti One prastha of oil should be cooked by adding two prasthas of each of cow’s urine and cow’s milk and the paste of one karsa of each of Guduchi, Malati, Rasna, Bala, Madhuka, Citraka, Nidigdhika, Devadaru and Yuthika. A tampoon soaked with this medicated oil should be inserted into the vagina and this oil may gynecic diseases caused by Vayu. be administered in the form of douche for curing gynicological disorder disease caused by Vayu .
योनी व प्रणयेदिति योनाबुत्तरवलिना प्रवेशयेत् । । ।  (Chakrapani)
             Chakrapani has taken the meaning ’उत्तर बस्ति’ from the ’योनौ च प्रणयेत्’.
            That why Guduchyadi Taila Uttar Basti has been used in this study.
 Rasnadi Ksheerpaka-
रास्नाश्वदंष्ट्रावृषकैः पिबेच्छूले श्रृतं पयः । । (A.H.U. 34/33)
Intake of the Shrit Payah /Ksheerpaka prepared by adding Rasna, Svadamshtra (gokshura) and Vrishak (vasa) cures the pain in reproductive organ.
 
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