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CTRI Number  CTRI/2023/09/057451 [Registered on: 12/09/2023] Trial Registered Prospectively
Last Modified On: 02/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical study of jalakumbhi kshar and varun shigru kwath in patients of garbhashaya Arbud with special reference to uterine fibroid. 
Scientific Title of Study   "A comparative clinical study to evaluate the efficacy of Jalakumbhi kshar and varun shigru kwath in the management of garbhashaya arbud with special reference to uterine fibroid. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Swati Rani 
Designation  M.S. Scholar Prasuti Tantra and Stri Roga 
Affiliation  State Ayurvedic College Lucknow  
Address  State Ayurvedic College and Hospital Lucknow Department of Prasuti Tantra and Stri Roga Tulsidas Marg Tudiyaganj Lucknow Uttar Pradesh

Lucknow
UTTAR PRADESH
226004
India 
Phone  7888375930  
Fax    
Email  swatisingh10992@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Kanchan Gupta 
Designation  M.D.(Ay.) H.O.D PG Department of Prasuti Tantra and Stri Roga  
Affiliation  State Ayurvedic College Lucknow  
Address  State Ayurvedic College and Hospital Lucknow Department of Prasuti Tantra and Stri Roga Tulsidas Marg Tudiyaganj Lucknow Uttar Pradesh

Lucknow
UTTAR PRADESH
226004
India 
Phone  8299452089  
Fax    
Email  251dockanchangupta@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prof Kanchan Gupta 
Designation  M.D.(Ay.) H.O.D PG Department of Prasuti Tantra and Stri Roga  
Affiliation  State Ayurvedic College Lucknow  
Address  State Ayurvedic College and Hospital Lucknow Department of Prasuti Tantra and Stri Roga Tulsidas Marg Tudiyaganj Lucknow Uttar Pradesh

Lucknow
UTTAR PRADESH
226004
India 
Phone  8299452089  
Fax    
Email  251dockanchangupta@gmail.com  
 
Source of Monetary or Material Support  
State Ayurvedic College and Hospital Tulsidas Marg Tudiyaganj Lucknow U.P. 226004 
 
Primary Sponsor  
Name  State Ayurvedic College and Hospital Lucknow  
Address  State Ayurvedic College and Hospital Lucknow Tulsidas Marg Tudiyaganj Lucknow Uttar Pradesh 226004 
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 Swati Rani   State Ayurvedic College and Hospital Lucknow   OPD No. 1 Department of Prasuti Tanta and Stri Roga State Ayurvedic College and Hospital Lucknow Tulsidas Marg Tudiyaganj Lucknow U.P.
Lucknow
UTTAR PRADESH 		 7888375930

swatisingh10992@gmail.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:D495||Neoplasm of unspecified behavior of other genitourinary organs. Ayurveda Condition: ARBUDAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Jalkumbhi kshar , Reference: Aushdha verga/1468, Kaidev Nighantu and Susrutra Sutra Sthan Adhyaya 11 , Route: Oral, Dosage Form: Kshara , Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -water), Additional Information: Duration- 3 concecutive cycles after cessation of menses
2Intervention ArmDrugClassical(1) Medicine Name: Jalkumbhi kshar , Reference: Aushdha verga/ 1468, Kaidev Nighantu and Susrutra Sutra Sthan Adhyaya 11 , Route: Oral, Dosage Form: Kshara , Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -water), Additional Information: Duration - 3 concecutive cycles after cessation of menses
(2) Medicine Name: Varun Shigru kwath , Reference: Dravyaguna Vigyanam by Acharya P.V Sharma part-2 , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: With equal amount of water ), Additional Information: Duration - 3 concecutive cycles after cessation of menses
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1. Patients of age group between 25-45 years.
2. Patients having Uterine fibroid size equal or less than 5 cm as per USG reprort.
3. Single or multiple Uterine fibroid up to 3. 4. Patients willing to participate in the study with proper written consent. 
 
ExclusionCriteria 
Details  1. Patient below the age of 25 years and above the age of 45 years.
2. Patient having fibroid size greater than 5cm as per USG reprort.
3. Uterine fibroid with pregnancy.
4. Lactating mother.
5. Woman with Hb less than 8gm/dl.
6. Patient with any coagulative diseases.
7. Patient using iucd or taking ocp.
8. Patient suffering from any other pelvic pathology.
9. Patient suffering from any chronic illness. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement of sign and symptoms of uterine fibroid.  60 days 
 
Secondary Outcome  
Outcome  TimePoints 
1.Improvement of sign & symptoms of uterine fibroid.
2. Reduced size of uterine fibroid. 		 90 days
 
 
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 1/ Phase 2 
Date of First Enrollment (India)   20/09/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  20/09/2023 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="1"
Days="3" 
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   The study is entitled to- A comparative clinical study to evaluate the efficacy of Jalkumbhi kshar and Varun Shigru kwath in the management of Garbhashaya Arbuda w.s.r Uterine fibroid.
 
Objective of study- To compare the efficacy of Jalkumbhi kshar and Jalkumbhi kshar alongwith Varun Shigru kwath in the management of Garbhashaya Arbuda w.s.r to Uterine fibroid.

Type of study- Randomised comparative open clinical trail.

Administration of trail therapy - Minimum 40 patients having symptoms of Garbhashaya Arbuda will registered into groups.

Group A- Jalkumbhi kshar 250 mg orally twice a day ( after clearance of menses)

Group B- Jalkumbhi kshar 250 mg orally twice a day and Varun Shigru kwath approx 50 ml in 2 divided dose orally ( after clearance of menses)

Duration of trail- Trail will be conducted for maximum 3 months.

Follow up - Next menstrual cycle after completion of treatment. To assess the efficacy of trail drugs.

Criteria of selection of patients -

 Pre assessment criteria - Patients from Prasuti tantra and Stri Roga OPD & IPD of State Ayurvedic College Lucknow will be screened out by the symptoms related to Uterine fibroid and USG reports.

Diagnostic Criteria - Diagnosis of each case will be made the help of detailed history in respect to disease, family history, previous similar episode, physical and systemic examination as well as the investigations.

Subjective Criteria - 1) Menstrual abnormalities ( Menorrhagia)
                                    2) Dysmenorrhea
                                    3) Pain and heaviness in lower abdomen
                                    4) Backache
                                    5) Frequent urination
                                    6) Constipation

Objective Criteria - USG ( lower abdomen)

Laboratory Examination - CBC , ESR
                                              CT , BT
                                              RBS
                                              LFT
                                              KFT
                                              Urine routine and microscopic
                                              Thyroid Profile ( if needed)
                                              USG.

Examination - Per Abdominal examination
                         Local examination of external genital
                         Per speculum examination
                         Per vaginal examination.
           
Assessment criteria - Total effect of therapy will be evaluated and grouped according to following criteria on the basis of assessment of sign and symptoms.
      Complete remission ( cured) - 100% relief in the symptoms.
      Marked improvement         -75-100% relief in the symptoms.
      Moderate improvement     - 50-74% relief in the symptoms.
      Mild improvement            - 25-49% relief in the symptoms.
      Unchanged                 - less than 25% of relief in symptoms. .

 





 
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