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CTRI Number  CTRI/2023/09/057997 [Registered on: 25/09/2023] Trial Registered Prospectively
Last Modified On: 12/09/2023
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 Shalmalyadi ghrita orally and Shalmalyadi ghrita Pichu in the patients of Asrigdara. 
Scientific Title of Study   A Comparative clinical study to evaluate the efficacy of Shalmalyadi Ghrita orally & Shalmalyadi Ghrita Pichu in the management of asrigdara with special reference to Dysfunctional Uterine bleeding.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nishika kaushal 
Designation  M.S. Ayurveda Research Scholar 
Affiliation  State Ayurvedic College and Hospital, Lucknow 
Address  PG Department of Prasuti Tantra evam Stri Roga, State Ayurvedic College and Hospital Lucknow UP
Tulsidas Marg, Turiyaganj, Lucknow, UP.
Lucknow
UTTAR PRADESH
226004
India 
Phone  9411800551  
Fax    
Email  luckeykaushal306@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shikha Sharma 
Designation  Lecturer 
Affiliation  State Ayurvedic College and Hospital, Lucknow 
Address  PG Department of Prasuti Tantra evam Stri Roga, State Ayurvedic College and Hospital Lucknow UP
Tulsidas Marg, Turiyaganj, Lucknow, UP.
Lucknow
UTTAR PRADESH
226004
India 
Phone  8743976379  
Fax    
Email  drshikhasharma1982@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shikha Sharma 
Designation  Lecturer 
Affiliation  State Ayurvedic College and Hospital, Lucknow 
Address  PG Department of Prasuti Tantra evam Stri Roga, State Ayurvedic College and Hospital Lucknow UP
Tulsidas Marg, Turiyaganj, Lucknow, UP.
Lucknow
UTTAR PRADESH
226004
India 
Phone  8743976379  
Fax    
Email  drshikhasharma1982@gmail.com  
 
Source of Monetary or Material Support  
State Ayurvedic College and Hospital Tulsidas Marg Lucknow Uttar Pradesh 
 
Primary Sponsor  
Name  State Ayurvedic college and Hospital Lucknow 
Address  State Ayurvedic college and Hospital tulsidas Marg Turiyaganj, Lucknow, UP 
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 Nishika kaushal  State Ayurvedic College and Hospital Lucknow  Department of Prasuti Tantra evam Stri Roga, OPD No. 1
Lucknow
UTTAR PRADESH 		 9411800551

kaushalnishi1915@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:N939||Abnormal uterine and vaginal bleeding, unspecified. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Shalmalyadi Ghrita, Reference: Yog ratnakar 30/42-43, Route: Oral, Dosage Form: Ghrita, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1.Adult married female who are in age group of 20-45years.
2.Patient willing for trial.
3.Patients simultaneously diagnosed with cardinal symptoms of Asrigdara / DUB (Excessive, prolonged and intermenstrual bleeding) .
 
 
ExclusionCriteria 
Details  1.Patients below 20 yrs and above 45 yrs.
2.Patients with Post menopausal bleeding
3.Patients with Hb less than 8 %
4.Patient with any other pelvic pathology(chronic cervicitis , fibroid and malignancy)
5.Patient on oral contraceptives, or using intrauterine contraceptive devices.
6.Patients with systemic diseases (diabetes mellitus, tuberculosis, jaundice, severe HTN).
7.VDRL, HIV, HBsAg positive patient.
8.Patients having coagulation disorders.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
1. To assess the efficacy of trial therapy on subjective parameters like Amount of menstrual bleeding, Duration of Menstrual cycle, Interval of Menstrual cycle , Passage of clots during menstruation, Pain during menstruation.
 		 2 months 
 
Secondary Outcome  
Outcome  TimePoints 
1.To assess the efficacy of trial therapy on subjective parameters like Amount of menstrual bleeding, Duration of Menstrual cycle, Interval of Menstrual cycle , Passage of clots during menstruation, Pain during menstruation.
 		 Follow up - On the clearance of each menstrual
cycle during the period of 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)   11/10/2023 
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="3"
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   Subject of the tittle-A Comparative clinical study to evaluate the efficacy of Shalmalyadi Ghrita Orally & Shalmalyadi Ghrita Pichu in the management of Asrigdara with special reference to Dysfunctional Uterine Bleeding. 
Objective of the Study- To compare the efficacy of Shalmalyadi Ghrita Pichu and Shalmalyadi Ghrita Pichu along with oral intake in the management of Asrigdara w.s.r to Dysfunctional Uterine bleeding. 
 Type of study-Randomized open level parallel clinical trial.
Administration of trial therapy-
 Sample size- Minimum 40 patients.
 Group A- –In this group patients will be treated with SHALMALYADI GHRITA 6 g BD orally with anupan of lukewarm water after meals and SHALMALYADI GHRITA SOAKED PICHU locally kept in the vagina for 7 days after cessation of menstrual cycle .
 Group B- In this group patients will be treated with SHALMALYADI GHRITA SOAKED PICHU locally kept in the vagina for 7 days after cessation of menstrual cycle.
Duration of Trial– 3 Months
Follow up during treatment – after each menstrual cycle for 3 consecutive months.
Follow up After Treatment:- On the clearance of next one successive menstrual cycle after completion of trial.
DIAGNOSTIC CRITERIA
Diagnosis of each case will be made with the help of detailed history in respect to disease, family history, previous similar episode, physical and systemic examination as well as the investigation.
SUBJECTIVE DIAGNOSTIC PARAMETERS
Cardinal Symptoms of Asrigdara
• Amount of menstrual bleeding
• Duration of Menstrual cycle
• Interval of Menstrual cycle
• Passage of clots during menstruation
• Pain during menstruation
OBJECTIVE CRITERIA: Hb%,       
INCLUSION CRITERIA: -
➢ Adult married female who are in age group of 20-45years.
➢ Patient willing for trial.
➢ Patients simultaneously diagnosed with cardinal symptoms of Asrigdara / DUB (Excessive, prolonged and intermenstrual bleeding) .
EXCLUSION CRITERIA: -
➢ Patients below 20 yrs and above 45 yrs.
➢ Patients with Post menopausal bleeding
➢ Patients with Hb less than 8 %
➢ Patient with any other pelvic pathology(chronic cervicitis , fibroid and malignancy)
➢ Patient on oral contraceptives, or using intrauterine contraceptive devices.
➢ Patients with systemic diseases (diabetes mellitus, tuberculosis, jaundice, severe HTN).
➢ VDRL, HIV, HBsAg positive patient.
➢ Patients having coagulation disorders.
LABORATORY INVESTIGATIONS
1. Estimation of Hb%, TLC, DLC, ESR.
2. BT & CT
3. RBS
4. Urine examination (routine & microscopic)
5. TSH
6. LFT
7. KFT
8. USG
ASSESSMENTCRITERIA: -
The improvement will be assessed on the basis of relief in the sign and symptomsymptoms for the purpose. 




 
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