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CTRI Number  CTRI/2025/08/093271 [Registered on: 19/08/2025] Trial Registered Prospectively
Last Modified On: 18/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Clinical study to evaluate effect of shonithastapana ksheera basti with pushyanuga churna and sarasijamakarandadi churna in Abnormal uterine bleeding  
Scientific Title of Study   A Comparative Clinical Study to Evaluate the effect of SARASIJAMAKARANDADI CHURNA AND PUSHYANUGA CHURNA with SHONITASTHAPANA GANA SIDDHA KSHEERA BASTI in Management of ASRIGDARA with special reference to DYSFUNCTIONAL 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 Chaitra N 
Designation  Assistant professor  
Affiliation  Sri kalabyraweshwara ayurvedic medical college hospital research center  
Address  Department of Prasuti Tantra and Stree Roga Sri kalabyraweshwara ayurvedic medical college hospital research center RPC layout, Hampi Nagar vijaynagar

Bangalore
KARNATAKA
560104
India 
Phone  8123972387  
Fax    
Email  chaitranagendra81@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Chaitra N 
Designation  Assistant professor  
Affiliation  Sri kalabyraweshwara ayurvedic medical college hospital research center  
Address  Department of prasuti tantra stree roga Sri kalabyraweshwara ayurvedic medical college hospital research center RPC layout, Hampi Nagar Vijayanagar Bangalore

Bangalore
KARNATAKA
560104
India 
Phone  8123972387  
Fax    
Email  chaitranagendra81@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Chaitra N 
Designation  Assistant professor  
Affiliation  Sri kalabyraweshwara ayurvedic medical college hospital research center  
Address  Department of prasuti tantra stree roga Sri kalabyraweshwara ayurvedic medical college hospital research center RPC layout Hampi Nagar vijaynagar

Bangalore
KARNATAKA
560104
India 
Phone  8123972387  
Fax    
Email  chaitranagendra81@gmail.com  
 
Source of Monetary or Material Support  
Sri kalabyraweshwara ayurvedic medical college hospital research  
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Other [] 
 
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 ChaitraN  Sri kalabyraweshwara ayurvedic medical college hospital research center   Department of prasuti tantra stree roga 10 pipeline road RPC layout hampi Nagar vijaynagar bangalore 104
Bangalore
KARNATAKA 
8123972387

chaitranagendra81@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SKAMCH&RC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N920||Excessive and frequent menstruation with regular cycle. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-Basti karma (Procedure Reference: Charaka, Procedure details: Shonithastapana Ksheera basti -yoga basti)
(1) Medicine Name: Sarasijamakarandadi churna , Reference: Sahasrayoga , Route: Oral, Dosage Form: Churna/ Powder, Dose: 12(g), Frequency: bd, Duration: 1 Months
2Intervention ArmProcedure-Bastikarma (Procedure Reference: Charaka, Procedure details: Shonithastapana Ksheera basti)
(1) Medicine Name: Sarasijamakarandadi churna, Reference: Sahsrayoga, Route: Oral, Dosage Form: Churna/ Powder, Dose: 12(g), Frequency: bd, Duration: 1 Months
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  Patients between the age group of 18 to 50 years
Patients with lakshanas of asrigdara
History of excessive bleeding for at least two cycles
 
 
ExclusionCriteria 
Details  Patients with history of any systemic disorders and endocrinal disorders which interfere with the course of treatment
Patients using intrauterine contraceptive device
Patients with the history of any anatomical uterine pathology or any growth
Incomplete abortion
Patients below 18 years and above 50 years
Bleeding other than that of uterine origin
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduce in excessive bleeding   Treatment duration -3 consecutive cycles
Yoga basti and shamana ousadi
Follow up after 3 cycles  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   15/12/2025 
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="5"
Months="0"
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   Asrigdara is one of the most common gynaecological problems It refers to pradirana ie excessive flow of asrik It is the excessive or prolonged blood loss during menstruation with or without bleeding in intermenstrual period. Ayurvedic classics have mentioned various nidanas based on which the respective doshas get vitiated predominantly apana vayu vitiation takes place which affects the reproductive system and increases the artava pramana in the garbhashaya gata siras Asrigdara is of four types vataja pittaja, kaphaja and sannipataja and the lakshanas are based on the dosha predominance. According to Acharya Sushruta there is angamarda and pain symptoms present in all types of asrigdara with excessive vaginal bleeding that is seen as a samanya lakshana Complications include dourbalya, bharama murchha tama trishna daha pandu and tandra which usually seen in this condition
It can be correlated to the Dysfunctional uterine bleeding which is defined as a state of abnormal uterine bleeding without any clinically detectable organic systemic iatrogenic cause where pelvic pathology like tumour inflammation or pregnancy is excluded About 10-30 percentage of reproductive aged women suffer from this condition and the prevalence increases during menarche and peri-menopausal period This condition can cause many complications like anaemia and infertility, general debility, lack of concentration discomfort etc which can hamper day to day routine activities It is observed that sharp increase in the incidence today due to lifestyle food habits and stress Management of Dysfunctional uterine bleeding includes  hormonal medications including oral contraceptives non hormonal medications including NSAIDs and tranexamic acid, intrauterine devices and surgical management Medical management in contemporary science has potential side effects and most of the cases end-up in surgical intervention. According to studies hysterectomy operations are primarily performed for benign indications such as excessive menstrual bleeding, fibroids/cysts, uterine disorder and uterine prolapse in India. It is reported that some of these operations were lifesaving, some were only meant for treating nonfatal but severe conditions and some are unnecessary.
It is indicated that many of these causes were considered to be treatable and surgery could be avoided Hence there is a need to treat such cases with medicines that are potent enough to regularize the menstrual cycle with a normal flow and avoid surgical intervention
In the present study attempt is made to evalaute the efficacy of shonitasthapana gana siddha ksheera basti and shamanaousadis like Sarasija Makarandadi churna and Pushyanuga churna in Asrigdara

 
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