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Study to evaluate the effectiveness of Nilotpaladi churna in treating asrugdar(excessive menstrual bleeding) with a focus on menorrhagia

Phase 2/3
Not yet recruiting
Conditions
Excessive and frequent menstruation with regular cycle. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH, (2) ICD-10 Condition: N920||Excessive and frequent menstruation with regular cycle. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH, (3) ICD-10 Condition: N920||Excessive and frequent menstruation with regular cycle. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH,
Registration Number
CTRI/2025/06/089054
Lead Sponsor
Dr. Gavale Shital Tanaji
Brief Summary

Title

Randomized controlled clinical trial to evaluate the efficacy of Nilopaladi churna in the management of asrugdar with special referance to menorrhagia



Objective

To evaluate the efficacy of Nilotapaladi churna in the management of asrugdar with special reference to menorrhagia.

To define asrugdar in term of heavy menstrual bleeding.

To review the details of asrugdar in ayurveda literature.



Open simple randomized clinical study ,initial assesment and selection of patients

60 randomized selected patients of asrugdar will be divided in to two groups (trial group A and control group B)

Each group contains 30 patients. Informed written consent will be taken from each patients prior to research

Authentication and standardization of trial drug and control drug Nilotpadali churna will be done

Group A                                                                                                                          Group B

(Trial Group)                                                                                                                  (Control Group)

4gm Nilotapaladi churna TDS                                                                                     4gm Nilotapaladi churna TDS

for 3 cosecutive menstrual cycle in                                                                             for 3 consecutive menstrual cycle in

apankal with anupan honey                                                                                         apankal with anupan tandulodak or honey

Observation will be done up to 3 consequent menstrual cycle starting from 1st menstrual cycle of treatment

To trial group A Nilotapaladi churna will be give for 3 months

To control group B Pushyanug churna will be give for 3 months

All observed changes will be recorded

Follow up on 1st, 3rd, 5th day of menstrual cycle for 3 cycle

obsevation ,

Discussion,

Conclusion ,

Summary

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
Female
Target Recruitment
60
Inclusion Criteria
  • Age 18-45 year women Patients with excessive vaginal bleeding more than 4 days without having any pathogenesis Patient with per vaginal bleeding before & after Menses without having any pelvic organ pathogenesis Quantity of Menstrual blood must be greater than 80-100 ml/menstrual cycle Patient with absolute symptoms of Asrugdar like 1 Atyadhik raktastrav 2 Anrutukal raktastrav 3 katishool 4 Adhodarshool 5 Sarvangmard Patients having sign and symptoms of menorrhagia like Excessive vaginal bleeding Long duration of blood flow during menses Passage of deep clots Patient having any one of symptoms with or without bodyache, weakness, giddiness, anemia,etc.
  • Voluntary willing patients Patients irrespective of religion,cast,pathy,occupation Hb% 8 to more than 8gm%.
Exclusion Criteria

Patients having cervical, uterine polyp Patients having genital malignancy Patients suffering from HIV,STD, Hepatitis B Patients suffering from disorder like genital TB Patients with chronic illness Utwrine fibroid and other pelvic pathologies.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To study the efficacy of Nilotpladi churna orally in the management of Asrugdar with special referance to menorrhagia5 days
Secondary Outcome Measures
NameTimeMethod
1)To study the efficacy of Nilotpladi churna orally in the management of Asrugdar with special reference to menorrhagia2)To compaire the Nilotpladi churna orally with Pushyanug churna orally in the management of Asrugdar with special referance to menorrhagia

Trial Locations

Locations (1)

Late Kedari Redekar Ayurvedic Hospital And Research Centre

🇮🇳

Kolhapur, MAHARASHTRA, India

Late Kedari Redekar Ayurvedic Hospital And Research Centre
🇮🇳Kolhapur, MAHARASHTRA, India
DrShital Tanaji Gavale
Principal investigator
9284945638
shitalgavale1999@gmail.com

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