CTRI

FULL DETAILS (Read-only) -> Click Here to Create PDF for Current Dataset of Trial

CTRI Number

CTRI/2026/02/104478 [Registered on: 23/02/2026] Trial Registered Prospectively

Last Modified On:

20/02/2026

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda

Study Design

Randomized, Crossover Trial

Public Title of Study

Clinical study to Evaluate The Efficacy Of Pippalyadi Churna With Ghrita In Oligomenorrhoea.

Scientific Title of Study

Randomized Open Labelled Controlled Clinical Study to Evaluate The Efficacy Of Pippalyadi Churna With Ghrita In Oligomenorrhoea.

Trial Acronym

Nil

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Manjusha Rupchand Meshram
Designation	Assistant professor Phd scholar Prasuti tantra and streerog Department
Affiliation	Government Ayurved College Nanded
Address	Prasuti tantra and streerog Department ward no.69 Government Ayurved College Nanded Maharashtra 431601 India Nanded MAHARASHTRA 431601 India
Phone	9657017483
Fax
Email	drmanjushameshram@gmail.com

Details of Contact Person
Scientific Query

Name	Soudamini Sudhir Chaudhari
Designation	Professor Prasuti tantra and streerog Department
Affiliation	Government Ayurved College Nanded
Address	Prasuti tantra and streerog Department ward no.69 Government Ayurved College Nanded Maharashtra 431601 India Nanded MAHARASHTRA 431601 India
Phone	09657017483
Fax
Email	soudaminichaudhari@gmail.com

Details of Contact Person
Public Query

Name	Soudamini Sudhir Chaudhari
Designation	Professor Prasuti tantra and streerog Department
Affiliation	Government Ayurved College Nanded
Address	Prasuti tantra and streerog Department ward no.69 Government Ayurved College Nanded Maharashtra 431601 India Nanded MAHARASHTRA 431601 India
Phone	09657017483
Fax
Email	soudaminichaudhari@gmail.com

Source of Monetary or Material Support

Government Ayurved College and Hospital Nanded

Primary Sponsor

Name	Manjusha Rupchand Meshram
Address	Prasuti tantra and streerog Department ward no.69 Government Ayurved College Nanded Maharashtra 431601 India
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 Manjusha Rupchand Meshram	Government Ayurved College and Hospital Nanded	Prasuti tantra and streerog Department ward no.69 Maharashtra 431601 India Nanded MAHARASHTRA	09657017483 drmanjushameshram@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethical Committee Government Ayurved college and hospital Nanded	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:N915\|\|Oligomenorrhea, unspecified. Ayurveda Condition: ARTAVAKSHAYAH,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Comparator Arm	Drug	Classical		(1) Medicine Name: Shatpushpa Churna with Ghrita, Reference: Kashyap Samhita kalpasthan Shatpushpa ashatavari kalpa, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 10 Days, anupAna/sahapAna: Yes(details: -Ghrita), Additional Information: -
2	Intervention Arm	Drug	Classical		(1) Medicine Name: Pippalyadi Churna with Ghrita, Reference: Bhaishajya Ratnavali Yonivyapad rogadhikar, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 10 Days, anupAna/sahapAna: Yes(details: -Ghrita), Additional Information: -

Inclusion Criteria

Age From	18.00 Year(s)
Age To	40.00 Year(s)
Gender	Female
Details	Patients having primary or secondary Amenorrhea. Pregnant women, Lactating mothers, perimenopausal and menopausal women. Patients having PCOS with heavy menstrual bleeding and Hypogonadotropic, Hypogonadism, premature ovarian failure, and other pituitary ovarian syndrome. Patients take Oral Contraceptive Pills within 3 months, Hormonal therapy used for obesity and diabetes etc, taking radiation therapy within 3 years. Patients suffering from Endocrine disorders, Diabetic Mellitus, Thyroid dysfunction, Hyperprolactinemia, Cushing syndrome, Cardiovascular disorders Psychological, Epileptic disorders etc. Patients having Excessive menstrual bleeding disorders, systemic diseases like Tuberculosis, Anorectal bleeding, GIT tract Ulcers, STD Infections. Patients with any congenital anomalies, malignantlesions, obstructed and pelvic pathology in the reproductive system.

ExclusionCriteria

Details

Patients having primary or secondary Amenorrhea.
Pregnant women, Lactating mothers, perimenopausal and menopausal
women.
Patients having PCOS with heavy menstrual bleeding and
Hypogonadotropic, Hypogonadism, premature ovarian failure, and other
pituitary ovarian syndrome.
Patients take Oral Contraceptive Pills within 3 months, Hormonal therapy
used for obesity and diabetes etc, taking radiation therapy within 3 years.
Patients suffering from Endocrine disorders, Diabetic Mellitus, Thyroid
dysfunction, Hyperprolactinemia, Cushing syndrome, Cardiovascular
disorders Psychological, Epileptic disorders etc.
Patients having Excessive menstrual bleeding disorders, systemic diseases
like Tuberculosis, Anorectal bleeding, GIT tract Ulcers, STD Infections.
Patients with any congenital anomalies, malignantlesions, obstructed and
pelvic pathology in the reproductive system.

Method of Generating Random Sequence

Coin toss, Lottery, toss of dice, shuffling cards etc

Method of Concealment

Not Applicable

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
Efficacy of Pippalyadi churna evaluated by interval between two menstrual cycle and amount of menstrual bleeding increases for 3 consecutive menstrual cycle	10 days

Secondary Outcome

Outcome	TimePoints
NIL	NIL

Target Sample Size

Total Sample Size="120"
Sample Size from India="120"
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/ Phase 3

Date of First Enrollment (India)

03/03/2026

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="3"
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

This study is Randomized Open labelled Controlled Clinical study of efficacy of Pippalyadi Churna 5 gm with Ghrita 10 ml from 2 nd day of menstruation for 10 days in Oligomenorrhea for 3 menstrual cycle. This study will be carried out in 2 years of PG course.