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CTRI Number  CTRI/2024/11/076718 [Registered on: 12/11/2024] Trial Registered Prospectively
Last Modified On: 12/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to review the Effect Of Bandhyatavhar vati And Kumari tail Uttarbasti in the management of Infertility Tubal bloackage 
Scientific Title of Study   A Clinical Comparative Study To Evaluate The Efficacy Of Bandhyatavhar Vati And Kumari Tail Uttar Basti in The Managment of Stree Bandhyatav W.S.R Infertility Tubal bloackage 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Bharti 
Designation  Reasearch Scholar 
Affiliation  State Ayurvedic College And Hospital,Lucknow 
Address  Post Graduate Department of Prasuti Tantra and Stree Roga, Tulsidas Marg, Old Haiderganj, Lucknow, Uttar Pradesh 226001

Lucknow
UTTAR PRADESH
226001
India 
Phone  6396530420  
Fax    
Email  drbhartirajpoot2014@gmalil.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shashi Sharma 
Designation  Professor 
Affiliation  State Ayurvedic College And Hospital,Lucknow 
Address  Post Graduate Department of Prasuti Tantra and Stree Roga, Tulsidas Marg, Old Haiderganj, Lucknow, Uttar Pradesh 226001

Lucknow
UTTAR PRADESH
226001
India 
Phone  8795545443  
Fax    
Email  shashi.chd98@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shashi Sharma 
Designation  Professor 
Affiliation  State Ayurvedic College And Hospital,Lucknow 
Address  Post Graduate Department of Prasuti Tantra and Stree Roga, Tulsidas Marg, Old Haiderganj, Lucknow, Uttar Pradesh 226001

Lucknow
UTTAR PRADESH
226001
India 
Phone  8795545443  
Fax    
Email  shashi.chd98@gmail.com  
 
Source of Monetary or Material Support  
Post Graduate Department Of PrasutiTantra And Stree Roga ,State Ayurvedic College And Hosital,Lucknow,226001 
 
Primary Sponsor  
Name  State Ayurvedic College And HospitalLucknow 
Address  Tulsidas Marg, Old Haider Ganj, Khala Bazar, Old Labour Colony, Lucknow, Uttar Pradesh 226001 
Type of Sponsor  Government 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 Bharti  State Ayurvedic College And Hospital,Lucknow  Post Graduate Department of Prasuti Tantra and Stree Roga, Tulsidas Marg, Old Haiderganj, Lucknow, Uttar Pradesh 226001
Lucknow
UTTAR PRADESH 		 06396530420

drbhartirajpoot2014@gmalil.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, State Ayurvedic College and Hospital, Lucknow  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N00-N99||Diseases of the genitourinary system. Ayurveda Condition: VANDHYA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Bandhyatavhar Vati, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Lukewarm Water), Additional Information: -
2Comparator ArmProcedure-uttara-bastiH, उत्तर-बस्तिः (Procedure Reference: Charak Siddhi, Procedure details: Kumari Taila Uttar Basti DOSE- 5 Ml per day for 3 days for 3 months After Cessation of Menses)
(1) Medicine Name: Bandhyatavhar Vati, Reference: Bhavprakash, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Duration: 3 Months
 
Inclusion Criteria  
Age From  24.00 Year(s)
Age To  42.00 Year(s)
Gender  Female 
Details  1.Patients coming with primary and secondary infertility, 2.Patients coming with unilateral and bilateral tubal bloackage. 
 
ExclusionCriteria 
Details  1.Patients coming with inflammatory/infectious disease like PID,Endometriosis,etc,2.Patients coming with Menstrual disorder like Menorrhagia,Metrorrhagia,Secondary amenorrhea of more than three months,3.Patients coming with complaints of infertility with cervical/vaginal/unknown factor,4. Any congenital abnormalities of genital organ,5. Patients suffering with any systemic /acute illness  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Duration of Bleeding 2.Interval Between Two Cycle 3.Amount Of Blood Loss 4.Pain During Mensturation 5. Stress 6.Insomnia  Before Treatment,After 1 Month, After2 Month,After 3 Month, 1 Month After Treatment 
 
Secondary Outcome  
Outcome  TimePoints 
1.Conception
2.HSG (Hysterosalpingography) 		 Before Treatment, After 1 Month, After2 Month, After 3 Month, 1 Month After Treatment 
 
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 2 
Date of First Enrollment (India)   23/11/2024 
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="1"
Months="4"
Days="0" 
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   Plan Of Study

Material and Method
1. Conceptual study
2. Clinical study
1) Conceptual study- The available literature on ‘Bandhyattava’ and related
drug shall be collected from different Ayurvedic texts, modern texts, authentic
journals, internet and retrospective studies done in various institutions.
2)Clinical study-
 Sample source- All the patients will be registered from the OPD and IPD of Prasuti Tantra and Stree Roga Department of State Ayurvedic College and Hospital, Lucknow UP. In the present study, female patients of age group 24 to 42 years will be registered according to the Inclusion criteria.
Type of study- Randomized comparative parallel open clinical trial.
Sample size- minimum 40 patients will be registered.
Group allocation- total 40 patients will be registered randomly
from OPD &IPD of PTSR deptt. Of SAC lucknow.
Screened female will be randomly divided into two groups
Group A- patients of this group will be given the trial drug Bandhyatavhar vati in dose of 2tab BD (500mg each) given orally daily for 3 Consecutive cycle.
Group B- Patients of this group Will be given the trial drug Bandhyatavhar vati along with Uttar basti with kumari tail (5ml) for 3days after cessation of menses.

Treatment Schedule
All patients will be treated priorly with adhonabhigat snehana and swedana
soon after cessation of menses.
’ Uttar Basti’ will be given for 3 consecutive days, followed by per vaginal pichu insertion for 3- 4 hours daily. The same procedure will be executed in three consecutive cycles ( if needed).
Along with these, all patients will be treated with ‘Bandhyatavhar vati’ therapy daily for 3 consecutive cycles.
Follow up study Clinical assessment will be done after each menstrual cycle during trial. Final assessment will be done after completion of trial of 3 consecutive menstrual cycles. Case will be followed upto 2 menstrual cycles after completion of trial without any medication.
During trial- 2 follow ups
After trial- 2 follow ups
Mode of administration- The trial drug shall be administered orally and locally in the form of vati and
uttar basti respectively.
1. Bandhyatavhar vati-
 Dosage : 2 tab of Bandhyatavhar vati (250mg each) after meals.
 Anupan : Bandhyatavhar vati will be advised with lukewarm water
 Frequency of medication : 2 tab of Bandhyatavhar vati will be given for trial in morning and evening after meals daily for 3 continuous months .
2. Kumari taila -
Dosage : uttar basti from 5ml kumari taila.
Frequency of medication : 5ml of kumari taila uttar basti will be given through intravaginally for 3 consecutive days after clearance of menses for 3 consecutive cycles .

Criteria For Selection Of Patients
Pre assessment criteria: Patient from OPD and IPD of Prasuti Tantra
and Stree Roga Department of State Ayurvedic College, Lucknow will be screened out as per the inclusion criteria.
Diagnostic criteria: Diagnosis will be based on the presence of cardinal symptoms of ‘ Stree Bandhyattava’ as unable to conceive after 1 year of unprotected coitus.

1- Inclusion criteria-
A) Age between 24 to 42 years.
B) Patient coming with primary and secondary infertility
C) Patients coming with unilateral or bilateral tubal blockage.
D) Unknown factor (Idiopathic)

2- Exclusion criteria-
A) Patients coming with history of repeated abortion with Active
TORCH Profile (IgM positive).
B) Patients coming with menstrual disorder like- Menorrhagia,
Menometrorrhagia, Secondary Amenorrhea of more than three
months.
C) Patient suffering with any Systemic/ Acute illness.
D) Patient coming with any Genital organ diseases like- Uterine
fibroid, Genital Prolapse, Endometriosis, Adenomyosis, PID,
Genital tuberculosis, Hydrosalpinx etc.

Investigation
1- Hematological examination like- CBC, FBS, LFT, KFT
2- Hormonal profile (if needed) like- Serum LH/ FSH/TSH/
Prolactin/Estradiol/ Progesterone/ AMH.
3- USG (Uterus and Adnexa)
4- HSG
5- TORCH Profile (if needed)

Assessment Criteria
Assessment will be done on the basis of changes seen in the Subjective and Objective criterias.
1- All the signs and symptoms are graded as 0, 1, 2, 3.
2- The clinical improvement during and after trial will be correlated with previous intensity of sign and symptoms.

Subjective criteria
1- Abnormality in menstrual cycle like interval, duration, amount of bleeding, pain.
2- Other associated symptoms like stress, insomnia.

Objective criteria
1- Conception
2- HSG(Hysterosalpingography)

Clinical assessment of total effect of procedure
Maximum improvement- 75- 100% relief in the symptoms
Moderate improvement- 50- 75% relief in the symptoms
Mild improvement- 25- 50% relief in the symptoms
No improvement- <25% relief in the symptoms.
 
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