FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/10/075638 [Registered on: 22/10/2024] Trial Registered Prospectively
Last Modified On: 21/10/2024
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 To See Effect Of Dhataki Poogi Kusum Kashaya And Bhoomyamalaki Choorna With Tandulodaka In 60 Women Patient Having Menorrhagia That Is Heavy Or Prolonged Menstrual Bleeding  
Scientific Title of Study   A Randomized Comparative Clinical Study Of Dhataki Poogi Kusum Kashaya And Bhoomyamalaki Choorna With Tandulodaka In The Management Of Raktapradara With Special Reference To Menorrhagia  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Utkarsha Vishwas Lad 
Designation  Post graduate resident  
Affiliation  APMS Ayurveda Mahavidyalaya Sion Mumbai 
Address  Department Of Prasuti Tantra Evum Stree Roga 3rd Floor APMs Ayurved Mahavidyalaya Near Sion Railway Station Sion East Mumbai MAHARASHTRA

Mumbai
MAHARASHTRA
400022
India 
Phone  8208498015  
Fax    
Email  utkarshalad18@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Priya Jayant Walwatkar 
Designation  Assistant Professor 
Affiliation  APMS Ayurveda Mahavidyalaya Sion Mumbai 
Address  Department of Prasuti Tantra Evum Streeroga APMs Ayurved Mahavidyalaya sion near sion railway station Mumbai Mumbai 400022 Mumbai MAHARASHTRA

Mumbai
MAHARASHTRA
400022
India 
Phone  9820682568  
Fax    
Email  PriyaWalwatkar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Priya Jayant Walwatkar 
Designation  Assistant Professor 
Affiliation  APMS Ayurveda Mahavidyalaya Sion Mumbai 
Address  Department of Prasuti Tantra Evum Streeroga APMs Ayurved Mahavidyalaya sion near sion railway station Mumbai Mumbai 400022 Mumbai MAHARASHTRA

Mumbai
MAHARASHTRA
400022
India 
Phone  9820682568  
Fax    
Email  PriyaWalwatkar@gmail.com  
 
Source of Monetary or Material Support  
APMs Ayurved Mahavidyalaya sion near sion railway station sion east mumbai 400022 Maharashtra India 
 
Primary Sponsor  
Name  Utkarsha Vishwas Lad 
Address  APMs Ayurved Mahavidyalaya sion near sion railway station Mumbai Mumbai 400022 Mumbai MAHARASHTRA 
Type of Sponsor  Other [self] 
 
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 Utkarsha Vishwas Lad  APMs Seth R V Ayurvedic Hospital   OPD No 8 Department Of Prasuti Tnatra Evum Stree Roga 3rd floor APMs Ayurved Mahavidyalaya And Seth R V Ayurved Hospital near sion railway station Sion East Mumbai 400022
Mumbai
MAHARASHTRA 		 8208498015

utkarshalad18@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
APMs Ayurved Mahavidyalaya Sion IEC  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: RAKTAPITTAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Bhoomyamalaki choorna, Reference: Yogaratnakar pradarchikitsa adhyaya shloka no. 17, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Days, anupAna/sahapAna: Yes(details: -Tandulodaka), Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: Dhataki poogi kusum kashaya, Reference: Yogaratnakar pradarchikitsa adhyaya shloka no. 19, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  i. Patients of age 18 to 45 years.
ii. Patients with complaints of excessive bleeding per vagina during
menstruation.
iii. Patients ready to participate in study with proper written consent.
iv. Patient irrespective of religion, caste, parity, and socio-economic occupation will
be included.
 
 
ExclusionCriteria 
Details  i. Pregnancy.
ii. Post-menopausal bleeding.
iii. Known case of structural abnormality in genital organs.
iv. Know case of malignancy.
v. Cases diagnosed with pelvic pathologies like uterine fibroid, adenomyosis, polyp,
pelvic inflammatory disease, post-menopausal bleeding etc.
vi. Patients using any oral contraceptive pills or IUCD or hormonal therapy.
vii. Severe anemia 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1)Raja Strava Kala (Duration of bleeding)
2) Associated symptoms (Katishul, Adhodharshul, Angamarda)
3) Character of bleeding 		 3 DAYS OF MENSTRUAL CYCLE 
 
Secondary Outcome  
Outcome  TimePoints 
1)Raja strava Pramana (Amount of blood loss)
2) Anritu Kaal (Intermenstrual period)
3) No. of soaked pad / day
4)Relief of other associated symptoms. 		 3 DAYS OF MENSTRUAL CYCLE 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 4 
Date of First Enrollment (India)   01/11/2024 
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="6"
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   Menstruation is natural and normal physiological process leading to generative life in female. Normal Menstruation occurs after 21 to 35 days and last for 3 – 5 days with normal blood loss of 35-80 ml.

Menorrhagia is cyclic bleeding at normal intervals; the bleeding is either excessive in amount (>80ml) or duration (>7days) or both.

Acording to classical texts hetu sevan like excessive intake of lavan, amla, guru, katu vidahi, snigdha aahar, mansa, khichari, kheer, dadhi, alcohol etc. causes vitiation of vata which causes increase in Rakta (menstrual blood) amount and bring the increased amount of Rakta in Rajavahini seeras which results in increase in Raja. Raktapradara is caused by vitiated pitta and vata in association with Rakta.


Dhataki kusum has kashaya, katu rasa, sheeta virya and Poogi Kusum has madhur, kashaya rasa, sheeta virya which acts as Raktastambhak.5 Dhataki has potent antiinflammatory, antiandrogenic, antioxidant, astringent properties. Dhataki has katu vipak which work on mandagni present in Raktapradara. Poogi kusum is also antibacterial, antiseptic, astringent, vasoconstrictor, antioxidant in nature


In the view of cost, side effects and surgical interventions with modern medicine, the thought of exploring of Ayurvedic drugs which are having properties to reduce signs and symptoms of Raktapradara triggered this clinical research.
 
Close