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Clinical Trials/CTRI/2025/07/090263
CTRI/2025/07/090263
Not yet recruiting
Phase 2

A Randomized open labeled controlled clinical trial to assess an efficacy of Amalaki beej churna with Tandulodaka in the management of Asrugdara with special reference to menorrhagia

Manasi Nitin Sonawane1 site in 1 country60 target enrollmentStarted: July 15, 2025Last updated:
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Overview

Phase
Phase 2
Status
Not yet recruiting
Sponsor
Manasi Nitin Sonawane
Enrollment
60
Locations
1
Primary Endpoint
To determine the efficacy of Amalaki Beej churna with tandulodaka in Asrugdara W.S.R. to menorrhagia
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

This is a randomised, open-label, controlled clinical study to evaluate the efficacy of Amalaki beej churna with Tandulodaka orally in Asrugdara, which will be conducted in the OPD of Matoshri Asarabai Darade Ayurveda Mahavidyalaya, Babhulgaon. The primary outcome measures will be to assess the effect of the drug after 7th, 14th and 28th day, and the secondary outcome will be measured after 3 menstrual cycles during treatment and after 1 month after the treatment is completed.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
None

Eligibility Criteria

Ages
16.00 Year(s) to 45.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • •Selection irrespective of marital status, parity, socioeconomic status.
  • •Patients having signs and symptoms of Asrugdara.
  • •Excessive bleeding more than 2 consecutive cycles.
  • •Excessive bleeding (more than 80ml) or more than 7 days per vagina during mensuration.
  • •Hb more than 7 gm percentage.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

To determine the efficacy of Amalaki Beej churna with tandulodaka in Asrugdara W.S.R. to menorrhagia

Time Frame: 1 week,2 week,4 week,3 months

Secondary Outcomes

  • To study control on amount and duration of bleeding(To study efficacy in reducing associated symptoms)

Investigators

Sponsor
Manasi Nitin Sonawane
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Manasi Nitin Sonawane

Matoshree Asarabai Darade Ayurveda Mahavidyalaya Babhulgaon Tal-Yeola Dist-Nashik

Study Sites (1)

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