Womens health : Dysmenorrhea, IBS and Polyherbal Clinical Trials : How empathy, AI + Quantum could make things right

I have to start with a confession: I’ve felt a pretty significant degree of frustration discussing women’s health in the Indian ecosystem. Too often, it’s treated as an afterthought. Take the case of menstrual health, which is wrongly seen as a hygiene issue but not a healthcare issue. Given this starter bias and also historical imbalance in womens’ health research, the realm of investment scope gets limited to things like pads and menstrual cups. Even basic issues like Dysmenorrhea or IBS conditions that can cascade into serious complications are brushed aside. Our medical cannabis origins make conversations even harder to take towards a genuine meaningful conversation. I won’t lie, this may be the actual problem, which makes things a bit more sad.

Meanwhile, Israel and China are moving fast with a solving mindset pushing cannabinoid/polyherbal science (Yes, China too! where they may otherwise hang you for possession), running pragmatic trials, and evolving regulatory pathways. Western companies have even built entire models around “catching early Phase-I innovations in China” and purchasing rights for the West later. It’s smart and now crossed billions of dollars in value. Why, then, do we in India sitting at ground zero of mass ailments, struggle with impostor syndrome?

Silicon Valley is often accused of “privileged innovation,” and sure, it builds for affluent markets. But reminds me of the Jeff Bezos rule of unchangeables that applies almost everywhere: nobody wants things slower; nobody wants things more expensive. India can build better and more affordable health solutions precisely because we’re closest to the real-world burden.

I’m Indian and a father of two daughters. This is personal. After years of hitting walls trying to convey the long-term human and economic costs of ignoring these “everyday” ailments, I’ve decided to publish what we’ve learned, share our data, and invite anyone serious about solving this to work with us, wherever in the world you may be. We are currently supported by our pack of strays who have gotten us this far and we ain’t stopping.

The Hidden Burden (and Why This Should Be a Global Priority)

Prevalence :

  • Dysmenorrhea (menstrual pain) affects ~50–90% of post-pubertal women (definitions vary by severity). Presenteeism and absenteeism hit students and workers hardest.
  • IBS affects ~4–10% of adults globally (10–15% in some U.S. estimates), with women disproportionately impacted; IBS-D is ~one-third of cases.

Productivity and economic costs

  • Menstruation-related symptoms drive large productivity losses; one large study found ~8.9 days/year lost and ~33% presenteeism during symptomatic periods.
  • In Australia, women with chronic pelvic pain (including endometriosis/dysmenorrhea) face Int’l $16,970–$20,898 per woman/year, 75–84% due to productivity loss.
  • IBS carries heavy direct medical costs; U.S. estimates put annual direct costs ~US$6,182 per patient vs US$4,156 controls (2013 USD); additional studies show higher totals for subtypes and payer cohorts.
  • IBS also crushes on the job performance, older employee studies show ~15–21% productivity loss vs non-IBS peers.

Policy context

This burden touches multiple SDGs - SDG 6.2 (sanitation/hygiene, calling out needs of women and girls), SDG 3.7 (sexual & reproductive health services), SDG 5.6 (reproductive health/rights) even though “menstrual health” isn’t a standalone SDG indicator.

The funding tide is turning

In August 2025 the Gates Foundation committed US$2.5B through 2030 to women’s health R&D, explicitly including gynecological and menstrual health—its largest such allocation ever. Major outlets and the Foundation detail focus areas and the historic research gap.

Off-Label and Self-Medication: Real Harms We Can Measure

Because condition-specific therapies and trials rarely exist, many patients default to NSAIDs for dysmenorrhea and acid-suppressants/PPIs or H2 blockers for gut symptoms, often for years.

  • NSAIDs: The FDA flags community-acquired acute kidney injury precipitation risk from NSAIDs; chronic use increases risk of CKD, GI ulcer/bleeding, and liver toxicity.
  • PPIs (for “IBS-adjacent” reflux/dyspepsia self-treatment): Systematic analyses associate long-term PPI use with CKD/AKI and nutrient malabsorption (B12, iron, Mg, Ca), increasing risks of anemia and fractures.
  • NSAID+PPI paradox: While PPIs can protect the upper GI tract, recent large cohort work shows higher lower-GI bleeding risk with NSAID+PPI vs NSAID alone (HR ~2.84). ([PMC]
  • NSAIDs for IBS pain? Evidence reviews do not recommend NSAIDs for IBS pain control (and they may worsen gut side-effects).

Bottom line: off-label isn’t benign. It’s a slow-motion pipeline into kidney disease, GI bleeding, anemia/osteoporosis, and chronic pain that silently inflates future healthcare costs.

What Happens When Dysmenorrhea/IBS Are Poorly Managed or Ignored

Dysmenorrhea (and related gynecologic conditions)

  • Endometriosis progression → adhesions, chronic pelvic pain, infertility; the national burden runs into $7.4–$9.7B/year in Australia alone.
  • Adenomyosis & fibroids → heavier bleeding, worsening pain, surgical risks if unaddressed.
  • Chronic pain sensitization → repeated unmanaged pain “rewires” pain pathways.
  • Mental health → higher depression/anxiety and education/work disruption

IBS (when unmanaged or mis-managed)

  • Productivity: persistent ~15–21% loss in work productivity; presenteeism dominates. ([PubMed]
  • Comorbidity costs: comorbid depression/anxiety dramatically raises total costs (e.g., +$6,709 incremental direct costs with comorbid depression in one claims analysis). ([Value in Health]
  • Medication harms: chronic NSAIDs/PPIs add renal, GI, hematologic, and skeletal risks. ([U.S. Food and Drug Administration]

Polyherbal Solutions: The Missing Middle (and Why India Should Lead)

The modern regulatory/scientific machine was built around single molecules, great for acute/lethal diseases, but a poor fit for multi-component, non-fatal, high-prevalence conditions like dysmenorrhea and IBS. Result: polyherbal products are widely used but rarely trialed, so the world leans on off-label stop-gaps.

  • Israel has long led cannabinoid and plant-based research (from Mechoulam’s foundational work onward) and built supportive infrastructure for medical cannabis as an instructive template for polyherbal progress.
  • China has been reforming TCM regulation, approving new TCMs under evidence frameworks and pushing for multi-center, higher-quality trials explicitly tackling the evaluation gap for multi-component medicines.

Why this matters: Polyherbal formulations encode centuries of practice but face combinatorial complexity (dozens of actives; many targets). Traditional trial design treats this as “too messy.” That’s precisely where AI + Quantum excel.

Our Trial: What We Ran, Why We Restarted, and What We Learned

At HempStreet, we developed #FormulationFemme, a polyherbal microdosed cannabis-based formulation for dysmenorrhea, and conducted what we believe was the world’s first dysmenorrhea Phase-I clinical trial. It was rigorous, ethics-committee guided, and restarted once to ensure the best representation of both the ailment and the solution (i.e., tighter inclusion/exclusion and a formulation/endpoint setup reflecting real-world patients). Also, does feel pretty cool that this little scrappy company out of India led the world into this direction :slight_smile:

Key takeaways:

  1. Phase I is non-negotiable for mass ailments: human safety under ethics oversight is essential when use is chronic/recurrent.
  2. Off-label is not a strategy: one-size-fits-all NSAIDs/PPIs aren’t optimized for menstrual or IBS biology and may carry long-term risks.
  3. Cost/design are the chokepoints: under a single-molecule paradigm, Phase II/III for polyherbals is too complicated, expensive and too slow for most sponsors.

How Quantum-AI Makes Phase II/III Affordable (US$1–2M Range)

The playbook is to combine AI digital twins, synthetic/external controls, and quantum optimization for design choices:

  • Shrink enrollment with digital twins: simulate large, diverse populations; run 50–100 real participants for validation instead of thousands.
  • Ditch full control arms: use synthetic/external controls from real-world data where appropriate, already recognized in limited regulatory contexts.
  • Adaptive platforms: quantum optimizers help tune dose, subgrouping, and site selection in near-real-time to cut waste.
  • Virtualized execution: e-consent, remote monitoring, wearable endpoints → fewer sites, lower monitoring costs.
  • Smarter endpoints: early biomarkers and digital signals for faster, smaller trials.

Illustrative cost model

Who’s building the stack: SandboxAQ (AI+quantum platforms), isomorphic labs (DL for drug design), quantinuum (quantum chemistry/ML), Rigetti (optimization) and others are laying the rails for this hybrid future.

The Research Gap Is Real (and Funders Are Responding)

Women-specific conditions (beyond cancer) have historically received ~1% of pharma research funding, a failure now being addressed by new commitments like Gates’ US$2.5B (40+ targeted innovations across maternal, gynecologic/menstrual health, contraceptives, STIs).

This creates an opportunity to prioritize polyherbal, non-fatal ailments that drive massive hidden costs through presenteeism, absenteeism, and downstream comorbidities.

The Zero-to-One Opportunity (and a Call to Collaborate)

Imagine a world where:

  • Women aren’t left on NSAIDs/PPIs for years with growing renal/GI/bone risks.
  • Dysmenorrhea and IBS have trialed, labeled, polyherbal options, validated via Quantum-AI and RWD.
  • India leans into its scale and know-how to deliver global-first innovation - faster, better, more affordable

We’re ready to share all the years of data from our Phase-I program and the operational lessons we’ve learned.

Final Thought

Israel and China have shown this can be done. Western firms already buy early rights from those ecosystems. Silicon Valley may innovate for privileged markets, but it does innovate. India sits on the world’s densest burden of mass ailments. We have the patients, clinicians, traditional knowledge, data, and entrepreneurs. What we need now is the mindset.

Bezos’ rule stands: no one wants slower or more expensive. With AI + Quantum, polyherbal trials become faster and cheaper and we can make them better, too. With major funders stepping up, the path from improvisation to validation is open. We’ve reached out to all the western folks but would love to also work with any folks in the space from India.

I write this as an entrepreneur and as a father of two daughters. This matters to me deeply. It should matter to all of us.

Hey Abhishek,

Curious to know a few things…

  1. How does the AI/quantum approach translate into tangible trial efficiency or cost savings?

  2. The biggest roadblock for almost all the cannabis based ventures in the past decade or so has been the regulatory bottleneck inside India. What improvements and scope do you see that ensure this space opens up?

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Hey Shalem,

Fair questions. Let me answer as best as i can.

  1. How does the AI/quantum approach translate into tangible trial efficiency or cost savings?

Ans: The hypothesis is that it is able to avoid large human patient bases required for phase 2 and 3 by utilizing “digital twins” and other permutations of patient types. Having done a phase 1 clinical trial ourselves, we know how timelines and costs can go nuts, especially if you do it honestly and have to deal with patient dropouts etc. Phase 2 and 3 are exponentially more difficult and costly. However, in my note, i emphasized the idea of starting with mass ailments that are not fatality conditions at their onset but could cause considerable economic, quality of life and social costs in the short term and when not addressed or self medicated using off-label products, can lead to much more serious long term harm. Thus, Dysmenorrhea and IBS. Now this is just for a single molecule situation. In a polyherbal/ multiple molecule scenario, you can only imagine the difficulty in terms of permutations and combinations of interactions now not just between patient conditions and diversity and the molecule but actually between each molecule/ component of the medication as well. This automatically complicates the FDA approval cycle (however, there seems to be change coming) from anything that is not single molecule. Now, we know most of what we have around as single molecule based drugs were sythesized from the original usage as plants. And during our pioneering trial (we’re super proud that we are the world’s first and now licensing our IP overseas) we saw first hand how plant based polyherbal alternatives can product tangible medical benefits for certain mass ailments in a microdosed and non intoxicating way.

  1. The biggest roadblock for almost all the cannabis based ventures in the past decade or so has been the regulatory bottleneck inside India. What improvements and scope do you see that ensure this space opens up?

This is a common misconception especially around r&d. We are one of the few federally legal countries in the world. While cultivation remains illegal, and so do isolates (ie CDB, THC etc) we have zero restrictions on r&d. The large number of startups that entered the space were kind of trading in that no one saw beyond trying to find a gray area to sell cbdish stuff b2c. Very few ventured into actual product development and even fewer into trials. Of course, the fact that zero VC money has gone into the industry means that no one had the bandwidth to try anything risky. We were lucky in that we got money from believers who had life-changing experiences because of cannabis based therapy (all from overseas) and encouraged us to push the boundaries. So long story short, we looked at building world first stuff and have played the long game since 2019.

The US is only now federally legal for hemp derived which has made volumes go crazy which is why our partners there, after 4 years of product development gave us the go ahead to start in the US.

The irony is that guys like Dr. Reddy’s have acquired Cannabis API guys like Nimbus in Germany. Perhaps because they hired an Israeli CEO who’s more clued into whats happening abroad. India is already the pharmacy of the world and we have a chance to build global products, but empirical data would suggest that the appetite to fund anything that hasn’t been proven in the west first, is close to zero. We find a lot more enthusiasm for stuff that we do abroad than we do in India. We have a perfect storm of being the epicenter of most mass ailments (wish it wasnt true but it is what it is), a federally legal medical cannabis structure (less important for global markets but still) and a liberalized r&d regime. I hope more folks will have the opportunity that we had to go beyond the commoditized western rehashed models and India will produce another serum institute of India type institution that tackles global mass ailments in the cannabis space. We sure are trying :slightly_smiling_face:.

Thanks for asking these questions and always happy to explain to any depth if there are people to listen.