| CTRI Number |
CTRI/2025/11/097475 [Registered on: 14/11/2025] Trial Registered Prospectively |
| Last Modified On: |
14/11/2025 |
| 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 Palashmooladi Kwath in management of scanty menses
Rajahkshinta with special reference to oligomenorrhea |
|
Scientific Title of Study
|
Randomised controlled clinical trial to evaluate the effect of Palashmooladi Kwath in management of Rajahkshinta with special reference to oligomenorrhea. |
| 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 Priyanka Vishwasrao Motiwale |
| Designation |
Pg Scholar |
| Affiliation |
R A Podar Gov Ayurvedic Medical College |
| Address |
M A Podar Hospital R A Podar Gov Ayurvedic Medical college Worli Mumbai Opd No 8 Prasuti tantra evum strirog Department Mumbai 18 Maharashtra India
Mumbai
MAHARASHTRA
400018
India |
| Phone |
8805730024 |
| Fax |
|
| Email |
priyankamotiwale@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manoj Vitthal Gaikwad |
| Designation |
Professor |
| Affiliation |
R A Podar Gov Ayurvedic Medical College |
| Address |
M A Podar Hospital R A Podar Gov Ayurvedic Medical college Worli Mumbai Opd No 8 Department of Prasuti tantra evum strirog 18 Mumbai Maharashtra India
Mumbai
MAHARASHTRA
400018
India |
| Phone |
9822752816 |
| Fax |
|
| Email |
drmanojvgaikwad@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manoj Vitthal Gaikwad |
| Designation |
Professor |
| Affiliation |
R A Podar Gov Ayurvedic Medical College |
| Address |
M A Podar Hospital R A Podar Gov Ayurvedic Medical college Worli Mumbai Opd No 8 Department of Prasuti tantra evum strirog Mumbai 18 Maharashtra India
Mumbai
MAHARASHTRA
400018
India |
| Phone |
9822752816 |
| Fax |
|
| Email |
drmanojvgaikwad@gmail.com |
|
|
Source of Monetary or Material Support
|
| Opd no 8 Department of Prasuti tantra evum strirog M A Podar Hospital R A Podar Gov Ayurvedic medical college Worli Mumbai 18 Maharashtra 400018 |
|
|
Primary Sponsor
|
| Name |
R A Podar Gov Ayurvedic Medical College Worli Mumbai 18 |
| Address |
R A Podar Gov Ayu Medical College Dr Annie Besant Rd Worli Mumbai Maharashtra 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 Priyanka Vishwasrao Motiwale |
R A Podar Ayurvedic Medical College and Hospital |
Opd no 8 Prasuti tantra evum strirog Department Dr Annie Besant road Worli Mumbai 400018 Maharashtra India
Mumbai
MAHARASHTRA |
8805730024
Priyankamotiwale@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee R A Podar Ayurvedic Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N913||Primary oligomenorrhea. Ayurveda Condition: ARTAVAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shatpushspa churna, Reference: Bhavprakash , Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -water), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Palashmooladi kwath palashmool krishna til yastimadhu trikatu churna, Reference: Ras ratna Samuchayaya savimarshya rasprsbha author indradev triphati adhyaya 15 shlok no.88. author indradev triphati , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 12 Weeks, anupAna/sahapAna: Yes(details: -warm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1) Age limit – 18-45 years
2) Married & Unmarried Women
3) According to symptoms
A) Duration between 2 menses 35 days or more
B) Duration of bleeding for 3 or less than 3 days
C) Quantity of blood -scanty or less (having yonishul) |
|
| ExclusionCriteria |
| Details |
1) Pregnant, postnatal, lactating mother.
2) Thyroid disorder
3) other diseases like anaemia tuberculosis etc.
4) H.I.V / V.D.R.L/ HbsAg positive |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of Palashmooladi kwath in management of Rajah kshinta |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
o study the effect of Palashmooladi kwath in
a) Infrequent menses
b) Pain during menses
c) absence of menses |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
25/11/2025 |
| 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="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
|
Introduction The menstrual cycle known as Artavachakra is a
significant physiological aspect of femininity Garbhotpatti
is identical to Ankurotpatti of plants Garbh consists of
four basic factors Rutu Kshetra Ambu and Beeja The woman is responsible for two essential variables Kshetra and Beeja
As a female Kshetra it is essential to consider the reproductive System particularly Garbhashaya which is responsible for monthly flow and fertilized ovum The symptoms of artavakshaya
Yathochitakala adarshanam deals with amenorrhea
alpata hypomenorrhea oligomenorrhea
yonivedana vaginal pain Artavakshaya can be correlated w
ith menstrual disorders such oligomenorrhea and hypomeno
rrhea short menstrual cycles
Oligoamenorrhea is defined as irregular or inadequate menstrual bleeding Women with oligomenorrhea are those whose periods started normally and regularly but then became not frequent The period may occur at intervals longer than thirty five days Instead of twelve there could be only four to nine periods per year It could indicate a medical condition such as PCOS Other lifestyle variables such as emotional stress or excessive activity can also lead to this disease We have selected for oral administration in Palashmooladi kwath of Rajah kshinta the patients As per Ayurvedic literatures it has a property of remove dosas of Rajah It has katu tikta ras katu vipak and ushna virya By its aagney property it induces production of Rajah NEED OF STUDY
prevalence of menstruation diseases increases
due to changing lifestyle and improper
eating habits.
Failure of other medical systems Modern and alt
ernative treatments have often failed to provide co
mplete healing
Necessity of effective harmless and cost effective
therapy
Number of patient Group A Study group Thirty five patient will be administered Palashmooladi kwath Group B Control group Thirty five patient will receive Shatpushpadi churna Name of Investigations
CBC
BT CT
BSL F PP
LFT RFT LIPID PROFILE
Urine Routine Microscopic
HIV
HbsAg
VDRL
Following investigation were done before and after treatment in patient
ULTRASONOGRAPHY Pelvis 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 wholer esearch |