| CTRI Number |
CTRI/2026/03/106543 [Registered on: 19/03/2026] Trial Registered Prospectively |
| Last Modified On: |
19/03/2026 |
| 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
|
To study the effect of rasanjanadi chura and badar churna in the management of asrigdara with reference to menorrhagia |
|
Scientific Title of Study
|
Comparative Clinical Study To Evaluate The Efficacy of Rasanjandi Churna Yog And Badar Churna in The Management of Asrigdara( Menorrhagia) |
| Trial Acronym |
Nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deepika Digambar Sontakke |
| Designation |
MS Prasutitantra evum strirog scholar |
| Affiliation |
Ashvin rural ayurved college manchi hill tal sangamner |
| Address |
Prasuti tantr Evum strirog OPD Department of Prasutitantra Evum Strirog Ashvin rural ayurved college manchi hill tal sangamner
Ahmadnagar MAHARASHTRA 413714 India |
| Phone |
7507755571 |
| Fax |
|
| Email |
sontakkedeepika7@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Vishakha V Pachore |
| Designation |
Associate professor Prasutitantra Evum Strirog |
| Affiliation |
Ashvin rural ayurved college manchi hill tal sangamner |
| Address |
Prasuti tantr Evum strirog OPD Department of Prasutitantra Evum Strirog Ashvin rural ayurved college manchi hill tal sangamner
Ahmadnagar MAHARASHTRA 413714 India |
| Phone |
9975271980 |
| Fax |
|
| Email |
vishakha.pachore@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Vishakha V Pachore |
| Designation |
Associate professor Prasutitantra Evum Strirog |
| Affiliation |
Ashvin rural ayurved college manchi hill tal sangamner |
| Address |
Prasuti tantr Evum strirog OPD Department of Prasutitantra Evum Strirog Ashvin rural ayurved college manchi hill tal sangamner
Ahmadnagar MAHARASHTRA 413714 India |
| Phone |
9975271980 |
| Fax |
|
| Email |
vishakha.pachore@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of prasutitantra evum strirog ashvin rural ayurved college,manchi hill sangamner tal sangamner dist- ahemadnagr ,maharashtra, India pin code-413714 |
|
|
Primary Sponsor
|
| Name |
Ashvin rural ayurved college manchi hill |
| Address |
Department of Prasutitantra Evum Strirog Ashvin rural ayurved college manchi hill tal sangamner |
| Type of Sponsor |
Private 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 Deepika Digambar Sontakke |
Ashvin rural ayurved college manchi hill tal sangamner |
Prasutitantra Evum Strirog OPD Department of Prasutitantra Evum Strirog Ashvin rural ayurved college manchi hill tal sangamner Ahmadnagar MAHARASHTRA |
7507755571
sontakkedeepika7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee ashvin rural ayurved college manchi hill |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N926||Irregular menstruation, unspecified. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Rasanjandadi churna , Reference: Chakradatta , Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -tandulodak), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Badar churna, Reference: Chakradhar asrughdar adhyay , Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Guda), Additional Information: - |
|
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
patients complaining of heavy menstruation with other symptoms of asrigdara at least two consecuative cycle
the duration of bleeding must be greater than 7 days and quantity must be greater than 80 to 100 ml per cycle |
|
| ExclusionCriteria |
| Details |
patients having gross abnormalities of uterus and pelvis
patients sufferinf from severe anemia
patients with IUCD or OC pills |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| symptoms of Asrigadara like heavy bleeding and duration bleeding will be decreased and control over asrigadara |
3rd day 5th day and 7 th day of menses |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| decerease in symptoms of asrigadara |
18 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
|
N/A |
|
Date of First Enrollment (India)
|
05/04/2026 |
| 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 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
|
Ayurveda is an ancient System of holistic healing through herbs.In Women, it’s very important to keep her menstrual cycle normal. Menstrual Cycle is the Hormonal process a women goes through each month for few days. It is difficult task in dealing with Menstrual disorder one of most frequent encountered symptoms in Menorrhagia that is Asrigdara. Due to Pradirana (excessive excretion) of Raja it is named as Pradara, since there is Dirana(excessive excretion) of Asrk (menstrual blood) hence, it is known as Asrigdara. In charaka samhita Asrigdara is Classified under four group i.e vataja, pittaja,kaphaja and Sannipataja charaka has said that amount of blood within the vessels of uterus increases. As Explained in Sushruta, the Nidana is due to Consumption of Excess amount of kashya,amla,katu Anna there is Dusti or Rakta and Raja. The pitta in body further unites with Rakta and Raja further this Dushit Rakta and Raja unite with Vata in Garbha Shya, this further leads to excess amount of menstrual bleeding. According to Vagbhat , “ any abnormality in menstrual cycle leads to exessive and prolonged uterine bleeding which knows as Asrigdara. Ayurveda describes wide range of treatment options in the various forms like Churna , Swarasa, Kashaya, Hima, Phanta in Asrigdara. the main and primary treatment of Asrigdara is Raktastambak i.e haemostasis Rasanjandi Churna Yog and Badar churna is one means of Raktastambak in treatment of Asrigdara. Henc it becomes the need of few to find out an effective harmless therapy.
the prevalence of Menorrhagia varies widely but an incidence is about 10%
amongst new patient attending the out the patient. NEED OF STUDY The Menstrual Cycle is unaltered but duration and quantity of menstrual blood loss are increased.it is significant health care problem in the develop world due to change in food habits and busy life style of female. As this will affect the health and day to day life of women & cause serious illness to the the women. Various Management for Menorrhagia is given in modern medicine like Hormone replacement therapy and antifibronolytic agent having lots of side effect. If it not works they follows surgical intervention i.e. Hysterectomy. Hence to avoid such consequences the universe is looking forwards Ayurvedic management. Hence keeping this view in mind, I am selecting this topic and will work on it. As Ayurvedic text have described Rasanjanadi Churna yog and Badar churna is effective in the treatment of the Asrigdara. This makes researcher to focus on this topic. Knowledge Gap- The available allopathy treatment of Asrigdara includes hormonal therapy and other drugs which have serious side effect. There is no comparative study between Rasanjanadi churna and Badar churna . So this study will help to find out the most effective drug for over all management of Asrigdara. |