| CTRI Number |
CTRI/2025/06/089898 [Registered on: 30/06/2025] Trial Registered Prospectively |
| Last Modified On: |
16/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical study to evaluate the effect of Udumber twak churna along with tandulodak in Asrugdara W.S.R. To Menorrhagia |
|
Scientific Title of Study
|
A Randomised controlled clinical trial to evaluate the effect of Udumber Twak churna along with tandulodak in Asrugdara W.S.R. 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 |
Dr Reshma Hanumant Kanade |
| Designation |
PG Scholor |
| Affiliation |
R.A. Podar govt (Ayu) college Worli Mumbai |
| Address |
Opd no.8 Streeroga Prasutitantra Department , M.A. Podar hospital , R.A. Podar govt(Ayu) college Worli Mumbai 400018
Mumbai
Maharashtra
Mumbai
MAHARASHTRA
400018
India |
| Phone |
7219294853 |
| Fax |
|
| Email |
reshmahanumantkanade@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manoj Vitthal Gaikwad |
| Designation |
Hod Streeroga Prasuti Tantra Department |
| Affiliation |
R.A.podar govt (Ayu) college worli mumbai 400018 |
| Address |
Opd no 8 Streeroga prasutitantra department , M.A. Podar hospital , R.A. Podar govt (Ayu) college Worli mumbai 400018
Mumbai
Maharashtra
Mumbai
MAHARASHTRA
400018
India |
| Phone |
9822752816 |
| Fax |
|
| Email |
drmanojvgaikwad@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manoj Vitthal Gaikwad |
| Designation |
Hod Streeroga Prasuti Tantra Department |
| Affiliation |
R.A.podar govt (Ayu) college worli mumbai 400018 |
| Address |
Opd no 8 Streeroga prasutitantra department , M.A. Podar hospital , R.A. Podar govt (Ayu) college Worli mumbai 400018
Mumbai
Maharashtra
Mumbai
MAHARASHTRA
400018
India |
| Phone |
9822752816 |
| Fax |
|
| Email |
drmanojvgaikwad@gmail.com |
|
|
Source of Monetary or Material Support
|
| Opd no 8 streeroga prasutitantra department , M.A. Podar hospital , R.A. Podar govt (Ayu) College worli mumbai 18
PIN code 400018
Mumbai
Maharashtra |
|
|
Primary Sponsor
|
| Name |
R.A. Podar Govt (Ayu) College Worli mumbai 18 |
| Address |
R.A. Podar Govt (Ayu) College Worli Mumbai 18 Dr Anne Besat Road
PIN code 400018 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Reshma Hanumant Kanade |
Mahadevi Anandilal Podar government hospital |
Opd no 8 Streeroga prasutitantra department , R.A. Podar govt (ayu) college Worli mumbai 18
Dr Anne Besant road PIN code 400018
Mumbai
MAHARASHTRA |
7219294853
reshmahanumantkanade@gmail.con |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BORS Committee of Institution, R A Podar Govt Ayu College, Worli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E349||Endocrine disorder, unspecified. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Udumber twak churna, Reference: Bhavprakash 6, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -tandulodak), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Yashtimadhu twak churna and sita, Reference: Charak chikitsa 30, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -Tandulodak), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1 Increase in number of bleeding days in the menstrual cycle (Bleeding more than 5 days )
2 Decrease in intermenstrual period ( Period between two menstrual cycles less than 28 days )
3 Quantitatively increase in menstrual bleeding ( no of pad
4 patient having hb 8 g per dl or less than 8 g per dl
soakage per day that is more than 4 pad per day )
5Patient having Hb 8g per dl or less than 8g per dl |
|
| ExclusionCriteria |
| Details |
1 Pregnant women
2Patient with post menopausal bleeding
3Endocrinological disorders like hypothyroidism and hyperthyroidism
4 Patient with traumatic bleeding or abortive bleeding
5 Patient diagnosed with neoplasm ( ca uterus , ca cervix)
6 Patient having congenital anomaly of genital tract
7 Any systemic disease like diabetes Mellitus , Hypertension,coagulation disorder , cardiac arrest , antepartum haemorrhage, PIH patients
8 Patient with tubo ovarian mass
9 Patient using any IUCD
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1To study the effect of udumber twak churna with tandulodak in Asrugdara W.S.R. to Menorrhagia
2 To evaluate the effect of drug on
a. Amount of blood loss
b. Duration of bleeding days in asrugdara |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 To compare the effect of Udumber twak churna along with tanduloadak and yashtimadhu churna and Sita along with tandulodak in asrugdara
2 To collect the information about udumber twak and tanduloadak |
3 months |
|
|
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 3 |
|
Date of First Enrollment (India)
|
30/06/2025 |
| 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="1"
Months="0"
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
|
Nature has gifted a woman with energy of procreation. In womens life menstruation is a natural physiological phenomenon.Menstruation is a natural process which starts with menarche and ends with menopause. Menstruation and its abnormalities decides the womens general ,social and reproductive aspects of life.time Length of menstrual cycle is usually 21 to 35 days. Duration of is 5 to 7 days and the blood loss ranging between 20 to 80ml.As per modern science menorrhagia is defined as regular Cyclic bleeding Which is excessive in amount (more than 80ml) or duration (more than 7days) or both is termed as Menorrhagia . Since there is excessive evacuation of Raja (menstrual blood) that is Pradirana, the condition is termed as Pradara. Charaka say that increased amount of Rakta (blood) get mixed with Raja (menstrual blood), thus the quantity of Raja increases.As there is Dirana (excessive amount) of Asrik (menstrual blood) it is known as Asrugdara.Over the years, excessive and irregular uterine bleeding has become an increasingly frequent complaint. So we have selected Udumber Twak Churna with tandulodak for oral administration in patient with heavy menses.
NEED OF STUDY
Complication that may occur due to lot of blood loss over time is severe Anaemia.It also disturbs mental health of women suffering from Asrugdar.Clinical study on this combination for management of Asrugdara is not conducted yet so it is also essential to verify the facts of drug described in bhavprakash.So our drug of choice has kaphapittashamak and raktastambhak properties which will ultimately correct the pathology of disease and helps in subsiding the symptoms.
NUMBER OF PATIENTS Group A Study group 30 patients will be administered udumber twak churna along with tandulodak Group B Control group 30 patients will be administered yashtimadhu churna along and Sita along with tandulodak
INVESTIGATION CBC HIV HBSAG VDRL BT CT USG Cbc will be estimated before and after treatment
SUMMARY AND CONCLUSION
The work will be summarized to make final conclusions Observations of results will be concluded with statistical analysis under the heading ‘Conclusion’ with explanation at the end of whole research.
EXPECTED OUTCOME 1 Changes in subjectives by udumber twak churns along with tandulodak towards reduction in previous severity. 2 Effect of udumber twak churna along with tandulodak could be more than the effect of yashtimadhu churna and Sita along with tandulodak without any adverse effects . |