1. What data in particular will be shared?
   Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   
   
3. Who will be able to view these files?
   Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
   


4. For what types of analyses will this data be available?
   Response - Any purpose.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [usashinag96@gmail.com].
   


6. For how long will this data be available start date provided 01-01-2024 and end date provided 31-12-2028?
   Response - Beginning 3 months and ending 5 years following article publication.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - Nil

Prevalence of irregular menstrual cycle ranges from 81.7 to 96.3% and absenteeism from school due to menstrual discomfort ranges from 80.6 to 63.5%. Recent research suggested that homoeopathy is one of the most popular choices for women with various gynaecological disorders. This trial was aimed at differentiating individualized homoeopathic medicines (IHMs) from identical-looking placebos in the treatment of menstrual irregularities in women of the early reproductive age group. A four-month, double-blind, randomized (1:1), placebo-controlled trial was conducted on 92 females with menstrual irregularities at D. N. De Homoeopathic Medical College and Hospital. Participants were randomized into either verum (IHMs, n = 46) or control (placebos; n = 46). The primary outcome measure was the proportion of participants between groups in whom menstrual irregularities could be corrected. The secondary outcome was MDQ (Menstrual Distress Questionnaire) and its subscales. All the outcomes were measured at monthly intervals of up to 4 months. Group differences were estimated on the intention-to-treat sample. After 4 months of intervention, the group difference in the primary outcome was non-significant statistically (P = 0.835). The improvement observed in the MDQ total score and subscales scores were higher in the IHMs group than in placebos, however, statistically non-significant in most of the occasions, except for the behavioural change subscale (P < 0.001). Pulsatilla nigricans was the most frequently prescribed medicine. Kent’s Repertory and Complete were the most frequently used repertories. Overall the result remains inconclusive – the analysis fails to demonstrate clearly that IHMs were effective beyond placebos in most of the outcomes. More appropriate outcome measures should be sought for future trials.