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CTRI Number  CTRI/2025/05/086477 [Registered on: 07/05/2025] Trial Registered Prospectively
Last Modified On: 06/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Clinical Trail on Ayurvedic formulation in the management of Abnormal Uterine Bleeding. 
Scientific Title of Study   A randomised clinical trial to evaluate the effect of Yashtimadhu-Arjuna Ksheerpaka along with Dashmoola taila matra basti with and without Mruttika Chikitsa in Asrigdara w.s.r. to Abnormal Uterine Bleeding  
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 Dimpal Chouhan  
Designation  P.G Scholar 
Affiliation  National Insititude of Ayurveda Deemed to be University Jaipur 
Address  Department of Prasuti and Stri-Roga National Institute of Ayurveda Jaipur RAJASTHAN 302002 India

Jaipur
RAJASTHAN
302002
India 
Phone  8949455606  
Fax    
Email  dimpalchouhanraj1996@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Hetal H Dave 
Designation  Associate professor 
Affiliation  national institute of ayurveda jaipur rajasthan 
Address  Department of Prasuti and Stri-Roga National Institute of Ayurveda Jaipur RAJASTHAN 302002 India

Jaipur
RAJASTHAN
302002
India 
Phone  9251758867  
Fax    
Email  hetal.psr@nia.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Dimpal Chouhan  
Designation  P.G Scholar 
Affiliation  National Insititude of Ayurveda Deemed to be University Jaipur 
Address  Department of Prasuti and Stri-Roga National Institute of Ayurveda Jaipur RAJASTHAN 302002 India

Jaipur
RAJASTHAN
302002
India 
Phone  8949455606  
Fax    
Email  dimpalchouhanraj1996@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda Pharmacy Department,jorawar singh gate,amer road, Jaipur,rajasthan, 302002 india 
 
Primary Sponsor  
Name  National Institute of Ayurveda 
Address  National Institute of Ayurveda, (Deemed to be University), Jorawarsingh Gate, Jaipur Rajasthan 302002 
Type of Sponsor  Other [Government Ayurveda 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 Dimpal chouhan   OPD and IPD of National Insitute of Ayurveda  OPD no. 26 and 27 of National Institute of Ayurveda, (Deemed to be University), Jorawarsingh Gate, Jaipur, Rajasthan-302002
Jaipur
RAJASTHAN 
8949455606

dimpalchouhanraj1996@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE NATIONAL INSTITUTE OF AYURVEDA   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N921||Excessive and frequent menstruation with irregular cycle. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: charak samhita, Procedure details: Dashmoola taila matra basti 60 ml per rectal late noon (immediately after meal-Aadrapani) For 7 days on alternative days from 9th day of cycle to 21st day of cycle))
(1) Medicine Name: Yashtimadhu-arjuna ksheerpaka, Reference: Yog ratnakara raktapittarogadhikar 10/35-36, Route: Oral, Dosage Form: Ksheerpaka, Dose: 5(g), Frequency: bd, Duration: 60 Days
2Intervention ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: charak samhita, Procedure details: Dashmoola taila matra basti 60ml per rectal late noon (immediately after meal- Aadrapani) for 7 days on alternative days from 9th day of cycle to 21st day of cycle ))
(1) Medicine Name: Drakshadi churna, Reference: Shushruta uttar tantra 45/34, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Duration: 60 Days
3Comparator ArmProcedure-lepa, लेप (Procedure Reference: charaka samhita, Procedure details: Mruttika chikitsa local application . Krishna Mruttika lepa for 30min below the umbilicus from 22nd day to 28 days of the cycle and Dashmoola taila matra basti 60 ml per rectal late noon (immediately after meal-Aadrapani) For 7 days on alternative days from 9th day of cycle to 21st day of cycle )
(1) Medicine Name: Yashtimahu-arjuna ksheerapaka, Reference: yoga ratnakar raktapittadhikara 10/35-36, Route: Oral, Dosage Form: Ksheerpaka, Dose: 5(g), Frequency: bd, Duration: 60 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  Patients presenting with any two of the following symptoms
Heavy menstrual bleeding (amount more than 80ml) (PBLAC parameters) or
Prolonged menstrual bleeding (With the duration of bleeding more than 7 days) or
Inter menstrual bleeding
Patients of age group 18 to 50 years.
Hb% equal to or more than 8gm/dl 
 
ExclusionCriteria 
Details  Pregnant women.
Patient having Post-menopausal bleeding.
Patients having bleeding due to abortion and childbirth.
Patients using Intra uterine contraceptive device.
Patient having any known case of coagulation disorders.
Patient having any known case of malignancy..
Patients having known case of STDs.
Patients having any known case of systemic diseases.
Known case of Uterine and Pelvic pathology like- Polyps, Fibroid, Adenomyosis, Pelvic inflammatory disease. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Achievement of Normal Menstruation.  2 months  
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in quality of life.  2 months  
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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)   01/07/2025 
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="0"
Months="2"
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   PRIMARY PURPOSE - Treatment
NEED OF THE STUDY - One of the most common gynaecological issue affecting women during their reproductive year is Asrigdara. Asrigdara or Abnormal uterine bleeding is of more concern, because excessive or prolonged bleeding may cause undue disruption of woman’s daily activities & affects woman’s health both physically and psychologically. The incidence rate of Asrigdara is increasing day by day, so if treatment is delayed this can lead to a worsen condition of the patient due to excessive blood loss. According to FIGO, AUB is most common complaint in gynecology. It accounts for 70% of all gynecologic consults, affects 1/3 of women at some stage in their life. The estimated worldwide prevalence is about 4 to 52%. In India its prevalence is about 17.9%. If Asrigdara" is not treated properly, it can cause further complications like Daurbalya, Bhram, Paandu, anaemia, excessive bleeding can even cause death.

Various treatment modalities prescribed in modern medicine like hormonal treatment, anti-fibrinolytic agents, dilatation and curettage etc. have not proved their definite efficacy in spite of high price and side effects. Although the medical therapy is generally used first in which long term use of hormones like progestin may increase the risk of breast cancer. Dilatation and curettage can also stop the acute episode of excess uterine bleeding but not the subsequent episode, therefore the ultimate option for Menorrhagia is Hysterectomy. Morbidity is related with the amount of blood loss at the time of menstruation, which occasionally is severe enough to cause Hemorrhagic shock.

So, it is a great scope of research to find out safe, potent, cost effective remedy from Ayurveda by addressing the root of the problem thereby improving the quality of life of woman. Looking into the pathogenesis of Asrigdara, it occurs due to vitiation of Pitta, Rakta and Apana Vayu Vaigunya. In Asrigdara due to loss of Rakta dhatu other dhatus also. decreased and they lead to Agnimandya". Due to Agnimandya, Rasa Dhatu didn’t form properly and improper Rasa Dhatu leads to improper Rakta Dhatu formation. In other words, all seven Dhatus formed improperly. Along this, Upadhatu of Rasa i.e. Artava formation is also impaired. Thus, for the treatment of Asrigdara, the drug having the properties of Pittashamana, Vatanulomana, Raktasthapana, Raktasamgrahi, Agnidepana and Garbhashaya Balya etc. are used. So the drug which have capacity to break the pathogenesis, arrest the progression of disease, reduce risk of complications and relieve the symptoms should be used in Asrigdara.

There is no research has been done on Mruttika chikitsa in management of Asrigdra till date. Mruttika is easily available and cost effective too. Our Aacharyas have told mruttika chikitsa in Asrigdara. That is why this will be the first research on mruttika chikitsa in Asrigdara which improve quality life of women

These are the factors why the topic is being selected for the present study.
HYPOTHESIS
Null hypothesis [Ho1]: Madhuyashti-Arjuna Ksheerpaka & Drakshadi churna along with Dashmoola taila matra basti will be equally effective in Asrigdara w.s.r to Abnormal Uterine Bleeding.

[Ho2]: Madhuyashti-Arjuna Ksheerpaka along with Dashmoola taila matra basti with and without mruttika chikitsa will be equally effective in Asrigdara w.s.r to Abnormal Uterine Bleeding.

Alternate hypothesis [HAI]: Madhuyashti-Arjuna Ksheerpaka along with Dashmoola taila matra basti will be more effective than Drakshadi churna along with Dashmoola taila matra basti and vice-versa in Asrigdara w.s.r to Abnormal Uterine Bleeding.

[HA2]: Madhuyashti-Arjuna Ksheerpaka along with Dashmoola taila matra basti with mruttika chikitsa is more effective than Madhuyashti-Arjuna Ksheerpaka along with Dashmoola taila matra basti in Asrigdara w.s.r to Abnormal Uterine Bleeding.
RESEARCH QUESTION:

1. Is there any difference in the efficacy of Madhuyashti-Arjuna Ksheerpaka along with Dashmoola taila matra basti and Drakshadi churna along with Dashmoola taila matra basti and vice-versa in Asrigdara w.s.r to Abnormal Uterine Bleeding?

2. Is there any difference in the efficacy of Madhuyashti-Arjuna Ksheerpaka along with Dashmoola taila matra basti with mruttika chikitsa and Madhuyashti-Arjuna Ksheerpaka along with Dashmoola taila matra basti in Asrigdara w.s.r to Abnormal Uterine Bleeding?

AIM:
To evaluate the effect of Yashtimadhu-Arjuna ksheerpaka in Asrigdara w.s.r. to AUB with and without Mruttika chikitsa.

OBJECTIVES
Primary objectives:
To assess the effect of Madhuyashti-Arjuna Ksheerpaka along with Dashmoola taila matra basti in Asrigdara w.s.r. to Abnormal Uterine Bleeding.
To assess the effect of Drakshadi churna along with Dashmoola taila matra basti in Asrigdara w.s.r. to Abnormal Uterine Bleeding.
To assess the effect of mruttika chikitsa in Asrigdara w.s.r. to Abnormal Uterine Bleeding.
To compare the effect of group A & B.

Secondary objectives:
To assess improvement in the quality of life (SF-36).

Assessment Criteria
All the patients registered for the present trial will be assessed by following parameters:-
PBLAC(Pictorial blood loss assessment chart)
SF-36 Questionnaire
Amount of menstrual blood
Prolonged menstrual bleeding.
Intermenstrual Period.
Generalized Body Ache.
Lower abdominal pain during menstruation.
Burning Sensation in lower abdomen, low back, pelvis, kidneys, abdomen or uterus. Generalized weakness.

LABORATORY INVESTIGATIONS:
Before treatment
Complete blood count (CBC).
Erythrocyte sedimentation rate (ESR).
Clotting time (CT).
Bleeding time (BT).
Prothrombin time (PT).
Blood sugar postprandial
Urine Routine and Microscopic examination.
TSH

After treatment
Complete blood count (CBC)

 
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